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.

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.

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.

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.

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.

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.

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.

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.

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.

External validation of the Endovascular aneurysm repair Risk Assessment model in predicting survival, reinterventions, and endoleaks after endovascular aneurysm repair.

OBJECTIVE: The Endovascular aneurysm repair Risk Assessment (ERA) model predicts survival (early death, 3-year survival, and 5-year survival), reinterventions, and endoleaks after elective endovascular aneurysm repair. We externally validated the ERA model in our cohort of patients. METHODS: This was a retrospective validation study of 433 consecutive patients with an asymptomatic abdominal aortic aneurysm treated with endovascular aneurysm repair in three hospitals (Amsterdam, The Netherlands) between 1997 and 2010. The area under the receiver operating characteristic curve was used as measure of accuracy (>0.70 was considered as sufficiently accurate). RESULTS: The early death rate was 1% (3 of 433; 95% confidence interval [CI], 0%-2%), the 5-year survival rate was 65% (95% CI, 61%-70%), the 5-year reintervention rate was 18% (95% CI, 14-78%), and the 5-year rate of type I, II, or III endoleak was 25% (95% CI, 20%-29%). The areas under the curve varied between 0.64 and 0.66 for predictions of survival and between 0.47 and 0.61 for reinterventions and endoleaks. CONCLUSIONS: The predictions of survival, reinterventions, and endoleaks made by the ERA model were not sufficiently accurate to be used in our clinical practice.

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.

Ureterovesical anastomotic techniques for kidney transplantation: a systematic review and meta-analysis.

No consensus exists about which ureterovesical anastomosis technique to use for kidney transplantation. The aim of this systematic review was to compare the existing techniques in relation to the risk of urological complications. All studies that compared ureterovesical anastomotic techniques in kidney transplantation were included. Study endpoints were urinary leakage, ureteral stricture, vesicoureteral reflux and hematuria. Subanalyses of stented and nonstented techniques were performed. Two randomized clinical trials and 24 observational studies were included. Meta-analyses were performed on the Lich-Gregoir (LG) versus Politano-Leadbetter (PL) techniques and LG versus U-stitch (U) techniques. Compared with the PL technique, the LG technique had a significantly lower prevalence of urinary leakage (risk ratio (RR): 0.47, 95% confidence interval (CI): 0.30 to 0.75) and a significantly lower prevalence of hematuria when compared with both PL and U techniques (RR: 0.28, 95% CI: 0.16 to 0.49 and RR: 0.23, 95% CI: 0.11 to 0.50, respectively), regardless of ureteral stenting. There was no difference in the prevalence of ureteral strictures or vesicoureteral reflux between the various techniques. Of the three most frequently used ureterovesical anastomotic techniques, the LG technique results in fewer urological complications than the PL and U techniques.

Clinical relevance of routinely measured vital signs in hospitalized patients: a systematic review.

BACKGROUND: Conflicting evidence exists on the effectiveness of routinely measured vital signs on the early detection of increased probability of adverse events. PURPOSE: To assess the clinical relevance of routinely measured vital signs in medically and surgically hospitalized patients through a systematic review. DATA SOURCES: MEDLINE, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), Cumulative Index to Nursing and Allied Health Literature, and Meta-analysen van diagnostisch onderzoek (in Dutch; MEDION) were searched to January 2013. STUDY SELECTION: Prospective studies evaluating routine vital sign measurements of hospitalized patients, in relation to mortality, septic or circulatory shock, intensive care unit admission, bleeding, reoperation, or infection. DATA EXTRACTION: Two reviewers independently assessed potential bias and extracted data to calculate likelihood ratios (LRs) and predictive values. DATA SYNTHESIS: Fifteen studies were performed in medical (n = 7), surgical (n = 4), or combined patient populations (n = 4; totaling 42,565 participants). Only three studies were relatively free from potential bias. For temperature, the positive LR (LR+) ranged from 0 to 9.88 (median 1.78; n = 9 studies); heart rate 0.82 to 6.79 (median 1.51; n = 5 studies); blood pressure 0.72 to 4.7 (median 2.97; n = 4 studies); oxygen saturation 0.65 to 6.35 (median 1.74; n = 2 studies); and respiratory rate 1.27 to 1.89 (n = 3 studies). Overall, three studies reported area under the Receiver Operator Characteristic (ROC) curve (AUC) data, ranging from 0.59 to 0.76. Two studies reported on combined vital signs, in which one study found an LR+ of 47.0, but in the other the AUC was not influenced. CONCLUSIONS: Some discriminative LR+ were found, suggesting the clinical relevance of routine vital sign measurements. However, the subject is poorly studied, and many studies have methodological flaws. Further rigorous research is needed specifically intended to investigate the clinical relevance of routinely measured vital signs. CLINICAL RELEVANCE: The results of this research are important for clinical nurses to underpin daily routine practices and clinical decision making.

Competencies of specialised wound care nurses: a European Delphi study.

Health care professionals responsible for patients with complex wounds need a particular level of expertise and education to ensure optimum wound care. However, uniform education for those working as wound care nurses is lacking. We aimed to reach consensus among experts from six European countries as to the competencies for specialised wound care nurses that meet international professional expectations and educational systems. Wound care experts including doctors, wound care nurses, lecturers, managers and head nurses were invited to contribute to an e-Delphi study. They completed online questionnaires based on the Canadian Medical Education Directives for Specialists framework. Suggested competencies were rated on a 9-point Likert scale. Consensus was defined as an agreement of at least 75% for each competence. Response rates ranged from 62% (round 1) to 86% (rounds 2 and 3). The experts reached consensus on 77 (80%) competences. Most competencies chosen belonged to the domain 'scholar' (n = 19), whereas few addressed those associated with being a 'health advocate' (n = 7). Competencies related to professional knowledge and expertise, ethical integrity and patient commitment were considered most important. This consensus on core competencies for specialised wound care nurses may help achieve a more uniform definition and education for specialised wound care nurses.

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.

Decision aids for patients facing a surgical treatment decision: a systematic review and meta-analysis.

OBJECTIVE: To summarize the evidence available on the effects of decision aids in surgery. BACKGROUND: When consenting to treatment, few patients adequately understand their treatment options. To help patients make deliberate treatment choices, decision aids provide evidence-based information on the disease, treatment options, and their associated benefits and harms. Although decision aids are not designed to direct patients toward a particular treatment option, it is possible that their introduction will change the proportion of patients that opt for surgery. METHODS: We searched electronic databases for studies that evaluated a decision aid in patients offered both surgery and alternative treatment options, regarding the effect on the actual treatment choices made. In addition, we documented effects on knowledge, decisional conflict, anxiety, quality of life, patient involvement, satisfaction, mortality, morbidity, and costs. RESULTS: Seventeen studies were included. Overall, methodological study quality was good. Patients in the decision aid group less often chose to undergo invasive treatment [risk ratio = 0.80; 95% confidence interval, 0.67-0.95), had more knowledge about treatment options [mean difference = 8.99; 95% confidence interval, 3.20-14.78), and experienced less decisional conflict (mean difference = -5.04; 95% confidence interval, -7.10 to -2.99). Levels of anxiety and quality of life were similar. CONCLUSIONS: Offering a decision aid increases the number of patients who prefer conservative or less invasive treatment options. As decision aids improve patient knowledge and lower decisional conflict without raising anxiety levels, they have a place in surgery to help surgeons and patients achieve well-considered and shared treatment decisions.

Endovascular repair versus open repair of ruptured abdominal aortic aneurysms: a multicenter randomized controlled trial.

OBJECTIVE: Randomized comparison of endovascular repair (EVAR) with open repair (OR) in patients with a ruptured abdominal aortic aneurysm (RAAA). BACKGROUND: Despite advances in operative technique and perioperative management RAAA remains fraught with a high rate of death and complications. Outcome may improve with a minimally invasive surgical technique: EVAR. METHODS: All patients with a RAAA in the larger Amsterdam area were identified. Logistics for RAAA patients was changed with centralization of care in 3 trial centers. Patients both fit for EVAR and for OR were randomized to either of the treatments. Nonrandomized patients were followed in a prospective cohort. Primary endpoint of the study was the composite of death and severe complications at 30 days. RESULTS: Between April 2004 and February 2011, we identified 520 patients with a RAAA of which 116 could be randomized. The primary endpoint rate for EVAR was 42% and for OR was 47% [absolute risk reduction (ARR) = 5.4%; 95% confidence interval (CI): -13% to +23%]. The 30-day mortality was 21% in patients assigned to EVAR compared with 25% for OR (ARR = 4.4% 95% CI: -11% to +20%). The mortality of all surgically treated patients in the nonrandomized cohort was 30% (95% CI: 26%-35%) and 26% (95% CI: 20% to 32%) in patients with unfavorable anatomy for EVAR, treated by OR at trial centers. CONCLUSIONS: This trial did not show a significant difference in combined death and severe complications between EVAR and OR. Mortality for OR both in randomized patients and in cohort patients was lower than anticipated, which may be explained by optimization of logistics, preoperative CT imaging, and centralization of care in centers of expertise.

Changes in functional status after treatment of critical limb ischemia.

OBJECTIVE: This study evaluated changes in functional status with the Academic Medical Center Linear Disability Score (ALDS) and in quality of life with the Vascular Quality of Life Questionnaire (VascuQol) in patients treated for critical limb ischemia (CLI). METHODS: We conducted a prospective observational cohort study in a single academic center that included consecutive patients with CLI who presented between May 2007 and May 2010. The ALDS and VascuQol questionnaires were administered before treatment (baseline) and after treatment at 6 and 12 months of follow-up. Changes in functional status (ALDS) and quality of life (VascuQol) scores after 6 and 12 months, compared with baseline, were tested with the appropriate statistical tests, with significance set at P < .05. RESULTS: The study included 150 patients, 96 (64%) were men, and mean (± standard deviation) age was 68.1 (± 12.4) years. The primary treatment was endovascular in 98 (65.3%), surgical in 36 (24%), conservative in 11 (7.3%), or a major amputation in five (3.3%). The ALDS was completed by 112 patients after 12 months. At that time, the median ALDS score had increased by 10 points (median, 83; range, 12-89; P = .001) in patients who achieved limb salvage, which corresponds with more difficult outdoor and indoor activities. In patients with a major amputation, the median ALDS score decreased by 14 points (median, 55; range, 16-89; P = .117) after 12 months, which corresponds with domestic activities only. VascuQol scores improved significantly in all separate domains for the limb salvage group (P < .001). All VascuQol scores, except for the activity and social domains, increased significantly after amputation. CONCLUSIONS: Our study confirms the clinical validity of the ALDS in patients treated for CLI and shows that it is a valuable and sophisticated instrument to measure changes in functional status in these patients.

Fundamentals of randomized clinical trials in wound care: reporting standards.

In wound care research, available high-level evidence according to the evidence pyramid is rare, and is threatened by a poor study design and reporting. Without comprehensive and transparent reporting, readers will not be able to assess the strengths and limitations of the research performed. Randomized clinical trials (RCTs) are universally acknowledged as the study design of choice for comparing treatment effects. To give high-level evidence the appreciation it deserves in wound care, we propose a step-by-step reporting standard for comprehensive and transparent reporting of RCTs in wound care. Critical reporting issues (e.g., wound care terminology, blinding, predefined outcome measures, and a priori sample size calculation) and wound-specific barriers (e.g., large diversity of etiologies and comorbidities of patients with wounds) that may prevent uniform implementation of reporting standards in wound care research are addressed in this article. The proposed reporting standards can be used as guidance for authors who write their RCT, as well as for peer reviewers of journals. Endorsement and application of these reporting standards may help achieve a higher standard of evidence and allow meta-analysis of reported wound care data. The ultimate goal is to help wound care professionals make better decisions for their patients in clinical practice.

Fundamentals of randomized clinical trials in wound care: design and conduct.

The care for chronic and acute wounds is a substantial problem around the world. This has led to a plethora of products to accelerate healing. Unfortunately, the quality of studies evaluating the efficacy of such wound care products is frequently low. Randomized clinical trials are universally acknowledged as the study design of choice for comparing treatment effects, as they eliminate several sources of bias. We propose a framework for the design and conduct of future randomized clinical trials that will offer strong scientific evidence for the effectiveness of wound care interventions. While randomization is a necessary feature of a robust comparative study, it is not sufficient to ensure a study at low risk of bias. Randomized clinical trials should also ensure adequate allocation concealment and blinding of outcome assessors, apply intention-to-treat analysis, and use patient-oriented outcomes. This article proposes strategies for improving the evidence base for wound care decision making.