Grading recommendations for enhanced patient safety in sentinel event analysis: the recommendation improvement matrix.

OBJECTIVES: The goal of sentinel event (SE) analysis is to prevent recurrence. However, the rate of SEs has remained constant over the past years. Research suggests this is in part due to the quality of recommendations. Currently, standards for the selection of recommendations are lacking. Developing a method to grade recommendations could help in both designing and selecting interventions most likely to improve patient safety. The aim of this study was to (1) develop a user-friendly method to grade recommendations and (2) assess its applicability in a large series of Dutch perioperative SE analysis reports. METHODS: Based on two grading methods, we developed the recommendation improvement matrix (RIM). Applicability was assessed by analysing all Dutch perioperative SE reports over a 12-month period. After which interobserver agreement was studied. RESULTS: In the RIM, two elements are crucial: whether the recommendation intervenes before or after an SE and whether it eliminates or controls the hazard. Applicability was evaluated in 115 analysis reports, encompassing 161 recommendations. Recommendation quality varied from the highest, category A, to the lowest, category D, with category A accounting for 44%, category B for 35%, category C for 2% and category D for 19% of recommendations. There was a fair interobserver agreement. CONCLUSION: The RIM can be used to grade recommendations in SE analysis and could possibly help in both designing and selecting interventions. It is relatively simple, user-friendly and has the potential to improve patient safety. The RIM can help formulate effective and sustainable recommendations, a second key objective of the RIM is to foster and facilitate constructive dialogue among those responsible for patient safety.

Improving Shared Decision Making in Vascular Surgery: A Stepped Wedge Cluster Randomised Trial.

OBJECTIVE: Different treatment options are available and feasible for various vascular surgical disorders. Hence, vascular surgery seems an area par excellence for shared decision making (SDM), in which clinicians incorporate the patient's preferences into the final treatment decision. However, current SDM levels in vascular surgical outpatient clinics are below expectations. To improve this, different decision support tools (DSTs) have been developed: online patient decision aids, consultation cards, and decision cards. METHODS: This stepped wedge cluster randomised trial was conducted in 13 Dutch hospitals. Besides the developed DSTs, training on how to apply SDM during the clinician patient encounter was used in this study. Data were obtained via questionnaires and audio recordings. The primary outcome was the OPTION-5 score, an objective tool to assess the level of SDM, expressed as a percentage of exemplary performance. Main secondary outcomes were patients' disease specific knowledge, consultation duration, and treatment choice. Factors influencing OPTION-5 scores were studied using linear regression analysis. RESULTS: Included in the study were 342 patients with an abdominal aortic aneurysm (AAA; n = 87), intermittent claudication (IC; n = 143), or varicose veins (VV; n = 112). Audiotapes of 395 consultations were analysed. Overall the mean OPTION-5 score significantly improved from 28.7% to 37.8% (mean difference 9.1%, 95% CI 6.5% - 11.8%) after implementation of the DSTs. Also, patient knowledge increased significantly (median increase: 13%, effect size: 0.13, p = .025). The number of patients choosing non-surgical treatment choices increased, with 21.4% to 28.8% for patients with AAA and doubled (16.0% to 32.0%) among patients with IC. For surgeons, the SDM training and for patients the decision aid significantly and independently increased OPTION-5 scores (p < .001 and p = .047, respectively). CONCLUSION: Introducing DSTs improves the level of shared decision making in vascular surgery, improves patient knowledge, and shifts their preference towards more non-surgical treatments. The SDM training for clinicians and the decision aid for patients appeared the most effective means of improving SDM. TRIAL REGISTRATION: NTR6487.

Criteria for recommendations after perioperative sentinel events.

BACKGROUND: The recurrence of sentinel events (SEs) is a persistent problem worldwide, despite repeated analyses and recommendations formulated to prevent recurrence. Research suggests this is partly attributable to the quality of the recommendations, and determining if a recommendation will be effective is not yet covered by an adequate guideline. Our objectives were to (1) develop and validate criteria for high-quality recommendations, and (2) evaluate recommendations using the criteria developed. METHODS: (1) Criteria were developed by experts using the bowtie method. Medical doctors then determined if the recommendations of Dutch in-hospital SE analysis reports met the criteria, after which interobserver variability was tested. (2) Researchers determined which recommendations of Dutch perioperative SE analysis reports produced from 2017 to 2018 met the criteria. RESULTS: The criteria were: (1) a recommendation needs to be well defined and clear, (2) it needs to specifically describe the intended changes, and (3) it needs to describe how it will reduce the risk or limit the consequences of a similar SE. Validation of criteria showed substantial interobserver agreement. The SE analysis reports (n=115) contained 442 recommendations, of which 64% failed to meet all criteria, and 28% of reports did not contain a single recommendation that met the criteria. CONCLUSION: We developed and validated criteria for high-quality recommendations. The majority of recommendations did not meet our criteria. It was disconcerting to find that over a quarter of the investigations did not produce a single recommendation that met the criteria, not even in SEs with a fatal outcome. Healthcare providers have an obligation to prevent SEs, and certainly their recurrence. We anticipate that using these criteria to determine the potential of recommendations will aid in this endeavour.

Procedural Surgical RCTs in Daily Practice: Do Surgeons Adopt Or Is It Just a Waste of Time?

OBJECTIVE: To assess the adoption of recommendation from randomized clinical trials (RCTs) and investigate factors favoring or preventing adoption. BACKGROUND: RCT are considered to be the cornerstone of evidence-based medicine by representing the highest level of evidence. As such, we expect RCT's recommendations to be followed rigorously in daily surgical practice. METHODS: We performed a structured search for RCTs published in the medical and surgical literature from 2009 to 2013, allowing a minimum of 5-year follow-up to convincingly test implementation. We focused on comparative technical or procedural RCTs trials addressing the domains of general, colorectal, hepatobiliary, upper gastrointestinal and vascular surgery. In a second step we composed a survey of 29 questions among ESA members as well as collaborators from their institutions to investigate the adoption of surgical RCTs recommendation. RESULTS: The survey based on 36 RCTs (median 5-yr citation index 85 (24-474), from 21 different countries, published in 15 high-ranked journals with a median impact factor of 3.3 (1.23-7.9) at the time of publication. Overall, less than half of the respondents (47%) appeared to adhere to the recommendations of a specific RCT within their field of expertise, even when included in formal guidelines. Adoption of a new surgical practice was favored by watching videos (46%) as well as assisting live operations (18%), while skepticism regarding the methodology of a surgical RCT (40%) appears to be the major reason to resist adoption. CONCLUSION: In conclusion, surgical RCTs appear to have moderate impact on daily surgical practice. While RCTs are still accepted to provide the highest level of evidence, alternative methods of evaluating surgical innovations should also be explored.

Design and protocol of a comprehensive multicentre biobank for abdominal aortic aneurysms.

INTRODUCTION: The pathophysiology and natural course of abdominal aortic aneurysms (AAAs) are insufficiently understood. In order to improve our understanding, it is imperative to carry out longitudinal research that combines biomarkers with clinical and imaging data measured over multiple time points. Therefore, a multicentre biobank, databank and imagebank has been established in the Netherlands: the 'Pearl Abdominal Aortic Aneurysm' (AAA bank). METHODS AND ANALYSIS: The AAA bank is a prospective multicentre observational biobank, databank and imagebank of patients with an AAA. It is embedded within the framework of the Parelsnoer Institute, which facilitates uniform biobanking in all university medical centres (UMCs) in the Netherlands. The AAA bank has been initiated by the two UMCs of Amsterdam UMC and by Leiden University Medical Center. Participants will be followed during AAA follow-up. Clinical data are collected every patient contact. Three types of biomaterials are collected at baseline and during follow-up: blood (including DNA and RNA), urine and AAA tissue if open surgical repair is performed. Imaging data that are obtained as part of clinical care are stored in the imagebank. All data and biomaterials are processed and stored in a standardised manner. AAA growth will be based on multiple measurements and will be analysed with a repeated measures analysis. Potential associations between AAA growth and risk factors that are also measured on multiple time points can be assessed with multivariable mixed-effects models, while potential associations between AAA rupture and risk factors can be tested with a conditional dynamic prediction model with landmarking or with joint models in which linear mixed-effects models are combined with Cox regression. ETHICS AND DISSEMINATION: The AAA bank is approved by the Medical Ethics Board of the Amsterdam UMC (University of Amsterdam). TRIAL REGISTRATION NUMBER: NCT03320408.

Reporting of Complications and Mortality in Relation to Risk Communication in Patients with an Abdominal Aortic Aneurysm: A Systematic Review.

OBJECTIVES: High-quality reporting of surgical risks is necessary for evidence-based risk communication in clinical practice. Risk communication is defined as the process of discussing benefits and harms of treatment options with patients. This review addressed the current quality of reporting of complications and mortality in publications on abdominal aortic aneurysm treatment, with a focus on items relevant to risk communication. DESIGN: A systematic review. MATERIALS: Randomised clinical trials, comparative observational studies and registries from 2010 onwards were eligible if they reported complications and/or mortality in patients with an asymptomatic abdominal aortic aneurysms who received primary treatment. METHODS: Quality of reporting was assessed by scoring items relevant to risk communication from the reporting standards of the Society for Vascular Surgery (SVS) and the Consolidated Standards of Reporting Trials (CONSORT) statement. Screening, quality assessment and data extraction were independently undertaken by two authors. RESULTS: Forty-seven publications were included. Nine of 47 publications (19%) provided no definition of complications. In 14 of 47 publications (30%), it was unclear whether the number of adverse events or the number of patients with adverse events were presented. Absolute risk differences were provided in 1 of 32 publications (3.1%) that compared complications between two treatment options. Forty-six of 47 publications reported mortality, of which 42 reported overall mortality rates (91%). Absolute risk differences were given in 2 of the 31 publications (6.5%) that compared mortality between two treatment options. CONCLUSIONS: The quality of reporting of complications and mortality following primary abdominal aortic aneurysm treatment varied considerably. Better adherence to the SVS reporting standards and the CONSORT statement, as well as stating absolute risk differences may improve the quality of reporting and facilitate evidence-based risk communication.

Treatment of varicose veins, international consensus on which major complications to discuss with the patient: A Delphi study.

OBJECTIVE: To reach consensus on which complications of varicose vein treatments physicians consider major or minor, in order to standardize the informed consent procedure and improve shared decision-making. METHODS: Using the e-Delphi method, expert physicians from 10 countries were asked to rate complications as "major" or "minor" on a 5-point Likert scale. Reference articles from a Cochrane review on varicose veins were used to compose the list of complications. RESULTS: Participating experts reached consensus on 12 major complications: allergic reaction, cellulitis requiring intravenous antibiotics/intensive care, wound infection requiring debridement, hemorrhage requiring blood transfusion/surgical intervention, pulmonary embolism, skin necrosis requiring surgery, arteriovenous fistula requiring repair, deep venous thrombosis, lymphocele, thermal injury, transient ischemic attack/stroke, and permanent discoloration. CONCLUSION: An international consensus was reached about what physicians consider to be major complications of varicose vein treatments. This consensus may assist in standardizing the information physicians discuss with patients prior to varicose vein treatment.

Hyperbaric Oxygen Therapy in the Treatment of Ischemic Lower- Extremity Ulcers in Patients With Diabetes: Results of the DAMO2CLES Multicenter Randomized Clinical Trial.

OBJECTIVE: Conflicting evidence exists on the effects of hyperbaric oxygen therapy (HBOT) in the treatment of chronic ischemic leg ulcers. The aim of this trial was to investigate whether additional HBOT would benefit patients with diabetes and ischemic leg ulcers. RESEARCH DESIGN AND METHODS: Patients with diabetes with an ischemic wound (n = 120) were randomized to standard care (SC) without or with HBOT (SC+HBOT). Primary outcomes were limb salvage and wound healing after 12 months, as well as time to wound healing. Other end points were amputation-free survival (AFS) and mortality. RESULTS: Both groups contained 60 patients. Limb salvage was achieved in 47 patients in the SC group vs. 53 patients in the SC+HBOT group (risk difference [RD] 10% [95% CI -4 to 23]). After 12 months, 28 index wounds were healed in the SC group vs. 30 in the SC+HBOT group (RD 3% [95% CI -14 to 21]). AFS was achieved in 41 patients in the SC group and 49 patients in the SC+HBOT group (RD 13% [95% CI -2 to 28]). In the SC+HBOT group, 21 patients (35%) were unable to complete the HBOT protocol as planned. Those who did had significantly fewer major amputations and higher AFS (RD for AFS 26% [95% CI 10-38]). CONCLUSIONS: Additional HBOT did not significantly improve complete wound healing or limb salvage in patients with diabetes and lower-limb ischemia.

A Web-Based Application to Communicate Benefits and Risks of Surgical Treatments.

BACKGROUND: In general, communication is an important aspect during surgeon-patient consultations. However, clear communication of the benefits and risks of the possible treatment options can be challenging. Visual presentation of information may increase patient comprehension. We developed and piloted a web-based application that provides graphical representations of the numerical benefits and risks of surgical treatment options. MATERIALS AND METHODS: The app was developed by assessing functional requirements, developing a prototype, pilot-testing and adjusting the prototype, and evaluating the final app. In the app, the surgeon enters the benefits and risks of the surgical treatment options as percentages. The app shows the possible outcomes ad libitum as bar charts, icon arrays, or natural frequency trees. Subsequently, we investigated clinicians' and patients' satisfaction with the prototype by means of questionnaires, semi-structured interviews, and by observing their conversations. RESULTS: The MAPPING app ("Mapping All Patient Probabilities In Numerical Graphs") was pilot-tested among five surgeons and 12 patients with various surgical disorders. Nine patients welcomed the app and were eager to understand the risks and benefits involved when presented as graphs. The surgeons judged the app as simple to use and valuable. The prototype was improved based on their suggestions. CONCLUSION: The MAPPING app was developed successfully and has the potential to facilitate surgical risk communication in a more structured and uniform manner. Future research will focus on its validation and promotion of SDM in different types of patients and disorders.

The Merits of a Two-Day Evidence-Based Medicine Course for Surgical Residents.

BACKGROUND: Over 10 years ago, we introduced a two-day, evidence-based surgery course for surgical residents. During the last 4 years, we evaluated its effect on the participants' evidence-based medicine (EBM) knowledge and skills. METHODS: Between 2012 and 2015, six courses were organised for residents of various surgical specialties of allied hospitals in the Amsterdam educational district. The courses covered the literature search, critical appraisal of surgical papers, and how to communicate and weigh the benefits and harms of surgical interventions. Proficiency regarding interpreting evidence was tested before and directly after the course using a modified Berlin questionnaire. RESULTS: One hundred participants attended the courses, comprising residents in surgery (61 %), orthopaedics (16 %), urology (7 %), plastic surgery (7 %), and surgical PhD students (9 %), most of whom had already been taught EBM during their medical curriculum. Pre-course score levels were already fairly high (6.19 out of 10), but scores after the course were significantly higher (7.04); mean difference 0.85 (95 % confidence interval 0.4-1.3). No significant differences were observed among the surgical specialties. Attendees highly appreciated the course. CONCLUSIONS: A two-day, evidence-based surgery course improved EBM aptitude of surgical residents. Hence, the course appears useful to refresh the EBM paradigm among future Dutch surgeons.

[Unplanned hospital readmission: a meaningful quality indicator]. / Ongeplande heropname: een betekenisvolle kwaliteitsindicator.

Unplanned hospital readmission is an undesirable life event for the patient. There is some discussion whether hospital readmission is a reliable indicator of the quality of care. A recently developed classification system for hospital readmissions distinguishes between planned and unplanned readmissions. This classification system offers perspectives for the validation of readmission as a quality indicator and a better understanding of the relationship between admission and readmission.

Number Unnecessarily Treated in Relation to Harm: A Concept Physicians and Patients Need to Understand.

Physicians are legally and ethically compelled to present their patients with available evidence on the potentially beneficial and harmful effects of a proposed medical or surgical treatment. This, however, is only half the story. It does not offer the patient a clear view of the pros and cons of one treatment option versus another, or even versus no treatment at all. Explicitly stating the number of patients who will not benefit from the proposed treatment, in combination with the risk of a complication, may better inform patients and help them determine and express their treatment preference. This may also help standardize the informed consent procedure.

Shared Decision-Making in Surgery.

Medical treatment of patients always entails the risk of undesired complications or side effects. This is particularly poignant in surgery as both the disease to be treated and the surgical intervention to be performed can be life threatening. Hence, it is essential to inform a surgical patient in detail about the expectations desired, but also the possible undesired outcomes and complications, especially when new surgical techniques are introduced. Apart from communication about available evidence regarding treatment options, the patient's preference needs to be invoked to make sure the surgeon's advice matches the patient's preference. Shared decision-making (SDM) invokes the bidirectional communication between physicians and patients required to involve the patient's preference in the eventual treatment choice. SDM is considered as an essential part of evidence-based medicine as it helps determine whether the available evidence on the possible benefits and harms of treatment options match the patient's characteristics and preferences. This paper will exemplify what SDM is, why it is important, and how it can be performed in surgical practice. Several tools to facilitate SDM are presented.

Prednisolone-containing liposomes accumulate in human atherosclerotic macrophages upon intravenous administration.

Drug delivery to atherosclerotic plaques via liposomal nanoparticles may improve therapeutic agents' risk-benefit ratios. Our paper details the first clinical studies of a liposomal nanoparticle encapsulating prednisolone (LN-PLP) in atherosclerosis. First, PLP's liposomal encapsulation improved its pharmacokinetic profile in humans (n=13) as attested by an increased plasma half-life of 63h (LN-PLP 1.5mg/kg). Second, intravenously infused LN-PLP appeared in 75% of the macrophages isolated from iliofemoral plaques of patients (n=14) referred for vascular surgery in a randomized, placebo-controlled trial. LN-PLP treatment did however not reduce arterial wall permeability or inflammation in patients with atherosclerotic disease (n=30), as assessed by multimodal imaging in a subsequent randomized, placebo-controlled study. In conclusion, we successfully delivered a long-circulating nanoparticle to atherosclerotic plaque macrophages in patients, whereas prednisolone accumulation in atherosclerotic lesions had no anti-inflammatory effect. Nonetheless, the present study provides guidance for development and imaging-assisted evaluation of future nanomedicine in atherosclerosis. FROM THE CLINICAL EDITOR: In this study, the authors undertook the first clinical trial using long-circulating liposomal nanoparticle encapsulating prednisolone in patients with atherosclerosis, based on previous animal studies. Despite little evidence of anti-inflammatory effect, the results have provided a starting point for future development of nanomedicine in cardiovascular diseases.

Laser-assisted vessel welding: state of the art and future outlook.

Laser-assisted vascular welding (LAVW) is an experimental technique being developed as an alternative to suture anastomosis. In comparison to mechanical anastomosis, LAVW is less traumatic, non-immunogenic, provides immediate water tight sealant, and possibly a faster and easier procedure for minimally invasive surgery. This review focuses on technical advances to improve welding strength and to reduce thermal damage in LAVW. In terms of welding strength, LAVW has evolved from the photothermally-induced microvascular anastomosis, requiring stay sutures to support welding strength, to sutureless anastomoses of medium-sized vessels, withstanding physiological and supraphysiological pressure. Further improvements in anastomotic strength could be achieved by the use of chromophore-containing albumin solder and the employment of (biocompatible) polymeric scaffolds. The anastomotic strength and the stability of welds achieved with such a modality, referred to as scaffold- and solder-enhanced LAVW (ssLAVW), are dependent on the intermolecular bonding of solder molecules (cohesive bonding) and the bonding between solder and tissue collagen (adhesive bonding). Presently, the challenges of ssLAVW include (1) obtaining an optimal balance between cohesive and adhesive bonding and (2) minimizing thermal damage. The modulation of thermodynamics during welding, the application of semi-solid solder, and the use of a scaffold that supports both cohesive and adhesive strength are essential to improve welding strength and to limit thermal damage.

Outcomes of infrainguinal revascularizations with endovascular first strategy in critical limb ischemia.

PURPOSE: This study was designed to study the outcome of infrainguinal revascularization in patients with critical limb ischemia (CLI) in an institution with a preference towards endovascular intervention first in patients with poor condition, unfavourable anatomy for surgery, no venous material for bypass, and old age. METHODS: A prospective, observational cohort study was conducted between May 2007 and May 2010 in patients presenting with CLI. At baseline, the optimal treatment was selected, i.e., endovascular or surgical treatment. In case of uncertainty about the preferred treatment, a multidisciplinary team (MDT) was consulted. Primary endpoints were quality of life and functional status 6 and 12 months after initial intervention, assessed by the VascuQol and AMC Linear Disability Score questionnaires, respectively. RESULTS: In total, 113 patients were included; 86 had an endovascular intervention and 27 had surgery. During follow-up, 41 % underwent an additional ipsilateral revascularisation procedure. For the total population, and endovascular and surgery subgroups, the VascuQol sum scores improved after 6 and 12 months (p < 0.01 for all outcomes) compared with baseline. The functional status improved (p = 0.043) after 12 months compared with baseline for the total population. Functional status of the surgery subgroup improved significantly after 6 (p = 0.031) and 12 (p = 0.044) months, but not that of the endovascular subgroup. CONCLUSIONS: Overall, the strategy of performing endovascular treatment first in patients with poor condition, unfavourable anatomy for surgery, no venous material for bypass, and old age has comparable or even slightly better results compared with the BASIL trial and other cohort studies. All vascular groups should discuss whether their treatment strategy should be directed at treating CLI patients preferably endovascular first and consider implementing an MDT to optimize patient outcomes.

Is additional hyperbaric oxygen therapy cost-effective for treating ischemic diabetic ulcers? Study protocol for the Dutch DAMOCLES multicenter randomized clinical trial?

BACKGROUND: The value of hyperbaric oxygen therapy (HBOT) in the treatment of diabetic ulcers is still under debate. Available evidence suggests that HBOT may improve the healing of diabetic ulcers, but it comes from small trials with heterogeneous populations and interventions. The DAMOCLES-trial will assess the (cost-)effectiveness of HBOT for ischemic diabetic ulcers in addition to standard of care. METHODS: In a multicenter randomized clinical trial, including 30 hospitals and all 10 HBOT centers in the Netherlands, we plan to enroll 275 patients with Types 1 or 2 diabetes, a Wagner 2, 3 or 4 ulcer of the leg present for at least 4 weeks, and concomitant leg ischemia, defined as an ankle systolic blood pressure of <70 mmHg, a toe systolic blood pressure of <50 mmHg or a forefoot transcutaneous oxygen tension (TcpO2) of <40 mmHg. Eligible patients may be candidates for revascularization. Patients will be randomly assigned to standard care with or without 40 HBOT-sessions. RESULTS: Primary outcome measures are freedom from major amputation after 12 months and achievement of, and time to, complete wound healing. Secondary endpoints include freedom from minor amputations, ulcer recurrence, TcpO2 , quality of life, and safety. In addition, we will assess the cost-effectiveness of HBOT for this indication. CONCLUSION: The DAMOCLES trial will be the largest trial ever performed in the realm of HBOT for chronic ulcers, and it is unique for addressing patients with ischemic diabetic foot ulcers who may also receive vascular reconstructions. This matches the treatment dilemma in current clinical practice.

Predicting complex acute wound healing in patients from a wound expertise centre registry: a prognostic study.

It is important for caregivers and patients to know which wounds are at risk of prolonged wound healing to enable timely communication and treatment. Available prognostic models predict wound healing in chronic ulcers, but not in acute wounds, that is, originating after trauma or surgery. We developed a model to detect which factors can predict (prolonged) healing of complex acute wounds in patients treated in a large wound expertise centre (WEC). Using Cox and linear regression analyses, we determined which patient- and wound-related characteristics best predict time to complete wound healing and derived a prediction formula to estimate how long this may take. We selected 563 patients with acute wounds, documented in the WEC registry between 2007 and 2012. Wounds had existed for a median of 19 days (range 6-46 days). The majority of these were located on the leg (52%). Five significant independent predictors of prolonged wound healing were identified: wound location on the trunk [hazard ratio (HR) 0·565, 95% confidence interval (CI) 0·405-0·788; P = 0·001], wound infection (HR 0·728, 95% CI 0·534-0·991; P = 0·044), wound size (HR 0·993, 95% CI 0·988-0·997; P = 0·001), wound duration (HR 0·998, 95% CI 0·996-0·999; P = 0·005) and patient's age (HR 1·009, 95% CI 1·001-1·018; P = 0·020), but not diabetes. Awareness of the five factors predicting the healing of complex acute wounds, particularly wound infection and location on the trunk, may help caregivers to predict wound healing time and to detect, refer and focus on patients who need additional attention.

Acute kidney injury defined according to the 'Risk,' 'Injury,' 'Failure,' 'Loss,' and 'End-stage' (RIFLE) criteria after repair for a ruptured abdominal aortic aneurysm.

OBJECTIVE: Acute kidney injury (AKI) is a serious complication after repair of a ruptured abdominal aortic aneurysm (RAAA). In the present Society for Vascular Surgery (SVS)/International Society for CardioVascular Surgery (ISCVS) reporting standards patients are classified as no dialysis (grade I), as temporary dialysis (grade II), and as permanent dialysis or fatal outcome (grade III). However, AKI is a broad clinical syndrome including more than the requirement for renal replacement therapy. The recently introduced 'Risk,' 'Injury,' 'Failure,' 'Loss,' and 'End-stage' (RIFLE) classification for AKI comprises three severity categories based on serum creatinine and urine output ('Risk,' 'Injury,' and 'Failure'). The objective of the present study was to assess the incidence of AKI using the RIFLE criteria (AKIRIFLE). Secondary objectives were to assess the incidence of AKI as defined using the SVS/ISCVS reporting standards (AKISVS/ISCVS) and the association between AKIRIFLE and death. METHODS: This was an observational cohort study in 362 consecutive patients with an RAAA in three hospitals in Amsterdam (The Netherlands) between 2004 and 2011. The end points were the incidence of AKIRIFLE, of AKISVS/ISCVS, and the combined 30-day or in-hospital death rate. A multivariable logistic regression model was made to assess the association between AKIRIFLE and death after adjustment for preoperative shock profile (Glasgow Aneurysm Score) and postoperative shock profile (Acute Physiology and Chronic Health Evaluation [APACHE] II score, use of vasopressors, and fluid balance during the first 24 hours after intervention). RESULTS: AKIRIFLE occurred in 74% (267/362; 95% confidence interval [CI], 69%-78%), with 27% of these patients categorized as 'Risk' (71/267; 95% CI, 22%-32%), 39% categorized as 'Injury' (104/267, 95% CI, 33%-45%), and 34% categorized as 'Failure' (92/267; 95% CI, 29%-40%). AKISVS/ISCVS occurred in 48% (175/362; 95% CI, 43%-53%), with 53% of these categorized as 'grade I' (92/175; 95% CI, 45%-60%), 19% as 'grade II' (34/175; 95% CI, 14%-26%), and 28% as 'grade III' (49/175; 95% CI, 22%-35%). After multivariable adjustment for shock profiles the risk of dying in patients categorized as AKIRIFLE 'Failure' was greater than in patients without AKIRIFLE (adjusted odds ratio, 6.360; 95% CI, 2.231-18.130). CONCLUSIONS: The incidence of AKI defined according to the RIFLE criteria (74%) was greater than defined using the SVS/ISCVS reporting standards (48%) and patients categorized as 'Failure' using the RIFLE criteria had a greater risk of dying than patients without AKI. These results indicate that the problem of AKI is much bigger than previously anticipated and that minimizing injury to the kidney could be an important focus of future research on reducing the death rate after RAAA repair.

[Smarter hospital care]. / Slimmere ziekenhuiszorg.

The quality of hospital care is being questioned. This calls for decisions and innovations both in terms of care process and content. Innovations do not always have the desired effect and are often insufficiently supported by scientific evidence. The adoption and application of evidence-based principles in the organization as well as in the content of healthcare are therefore pivotal, not only for care professionals, but for hospital managers and decision makers as well. Implementation of these ideas appears most successful when conducted on different levels: national, strategic, tactical, and operational, and in educational as well as clinical settings.