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.

Editor's Choice - Post-operative Surveillance and Long Term Outcome after Endovascular Aortic Aneurysm Repair in Patients with an Initial Post-operative Computed Tomography Angiogram Without Abnormalities: the Multicentre Retrospective ODYSSEUS Study.

OBJECTIVE: Lifelong imaging surveillance is recommended following endovascular aneurysm repair (EVAR). This study aimed to examine the association between adherence to post-operative surveillance and survival and secondary interventions in patients with an initial post-operative computed tomography angiogram (CTA) without abnormalities. METHODS: All consecutive patients undergoing EVAR for intact abdominal aortic aneurysm (AAA) in 16 hospitals between 2007 and 2012 were identified retrospectively, with follow up until December 2018. Patients were included if the initial post-operative CTA showed no types I - III endoleak, kinking, infection, or limb occlusion. Discontinued follow up was defined as at least one 16 month period in which no imaging surveillance was performed. Primary outcomes were aneurysm related mortality and secondary interventions, and secondary outcome all cause mortality. Kaplan-Meier analysis was used to estimate survival, and Cox regression analyses to identify the association between independent variables and outcome. Sensitivity analyses were performed by varying the definition of continued yearly follow up. The study protocol was published (bmjopen-2019-033584). RESULTS: 1 596 patients (552 continued, 1 044 discontinued follow up) were included with a median (interquartile range) follow up of 89.1 months (52.6). Cumulative aneurysm related, overall, and intervention free survival was 99.4/94.8/96.1%, 98.5/72.9/85.9%, and 96.3/45.4/71.1% at 1, 5, and 10 years, respectively. American Society of Anesthesiologists (ASA) classification (ASA IV hazard ratio [HR] 3.810, 95% confidence interval [CI] 1.296 - 11.198), increase in AAA diameter (HR 3.299, 95% CI 1.408 - 7.729), and continued follow up (HR 3.611, 95% CI 1.780 - 7.323) were independently associated with aneurysm related mortality. The same variables and age (HR 1.063 per year, 95% CI 1.052 - 1.074) were significantly associated with all cause mortality. No difference in secondary interventions was observed between patients with continued vs. discontinued follow up (89/552; 16% vs. 136/1044; 13%; p = .091). Sensitivity analyses showed worse aneurysm related and overall survival in patients with continued follow up. CONCLUSION: Discontinued follow up is not associated with poor outcomes. Future prospective studies are indicated to determine in which patients imaging follow up can be safely reduced.

Development of three different decision support tools to support shared decision-making in vascular surgery.

BACKGROUND: Shared decision-making (SDM) is known to improve quality of care. Particularly in vascular surgery treatment options are often preference-sensitive. Unfortunately, vascular surgeons infrequently apply SDM. Decision support tools (DSTs) have been shown to be helpful in SDM. OBJECTIVE: This article describes the development process of three different DSTs to help vascular surgeons and patients apply SDM. PATIENT INVOLVEMENT: Patients' information needs were obtained via focus group meetings. Fifty-two patients and eighteen vascular surgeons not involved in the development process evaluated the comprehensibility and usability of the DST-prototypes. METHODS: A multidisciplinary steering group commissioned the development of the three DSTs according to international standards. RESULTS: Digital decision aids and paper-based consultation cards and decision cards were developed for patients with an abdominal aortic aneurysm, carotid artery disease, intermittent claudication or varicose veins. Patients preferred the use of the decision aids followed by consultation cards, whereas vascular surgeons preferred to use decision cards followed by decision aids. DISCUSSION: Decision aids, consultation cards and decision cards for four vascular diseases are now available to all vascular surgeons and patients in the Netherlands. The DSTs were well received by both surgeons and patients. English versions are also available.

Best-Worst Scaling Study to Identify Complications Patients Want to Be Informed About Prior to Abdominal Aortic Aneurysm Surgery.

BACKGROUND: Surgeons must discuss the most severe surgical complications with their patients while making a treatment decision. However, it is unclear which complications patients deem most severe. This study aimed to have patients classify potential complications following abdominal aortic aneurysm surgery based on severity using best-worst scaling. METHODS: Dutch patients with an abdominal aortic aneurysm, either under surveillance or following surgery, received a survey with 33 potential surgical complications. The survey presented these complications in sets of three. Patients had to classify one of three complications as most severe and one as least severe. After all participants had completed the survey, the number of times a complication was classified as most severe was subtracted from the number of times that the complication was classified as least severe, thus resulting in a best-worse scaling score. Complications with the lowest scores were ranked as more severe. RESULTS: Fifty out of 79 participating patients completed the survey in full. Patients classified the following ten complications as most severe: Below-ankle amputation, aneurysm rupture, stroke, renal failure, type 1 endoleak, spinal cord ischaemia, peripheral bypass surgery, bowel lesion, myocardial infarction and heart failure. Haematoma was ranked as the least severe complication. CONCLUSION: This best-worst scaling study enabled patients to classify complications following abdominal aortic aneurysm surgery based on severity. Vascular surgeons should discuss the ten complications deemed most severe with their patients and help their patients to effectively weigh the benefits of surgery against the harms patients themselves deem important, thereby improving shared decision making.

Risks following surgery that are discussed with patients prior to surgery often differ per surgeon. By law, surgeons are required to discuss the most common and most severe complications that may occur following surgery with their patients. But what do patients actually consider to be the most severe complications? In this study, we have asked this question to 50 patients with a widened abdominal aorta. These patients were approached via the Dutch patient organisation for people with cardiovascular diseases (Harteraad) and the Amsterdam University Medical Centres. From previous research, we collected 33 complications that may occur following surgery of the abdominal aorta. Using a survey, participating patients were shown three complications at a time. Of these three complications, they had to indicate which complication they considered the most severe complication and which the least severe complication. After all participants had completed their survey, we looked at how often a complication was deemed most severe and least severe. The ten most severe complications according to the participating patients were forefoot amputation, rupture of the widened abdominal aorta, stroke, kidney failure, leakage of blood along the aortic prosthesis, not enough blood supply to the spinal cord or bowels, a narrowing of the arteries in the leg, a heart attack and heart failure. We recommend that vascular surgeons discuss these ten severe complications with their patient, when a decision must be made about whether or not that patient should undergo surgery for their widened abdominal aorta. This will allow patients to weigh the benefits of the surgery against the risks they themselves deem important.

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.

Effect of Imaging Surveillance After Endovascular Aneurysm Repair on Reinterventions and Mortality: A Systematic Review and Meta-analysis.

Purpose: To study the effects of imaging surveillance after endovascular aortic repair (EVAR) on reintervention and mortality. Materials and Methods: A systematic review was conducted comparing complication rates in EVAR patients compliant with the imaging surveillance protocol vs partially or noncompliant patients. Two authors independently selected articles and performed quality assessment and data extraction. Risk differences for reintervention and mortality between compliant and partially/noncompliant patients were meta-analyzed. The pooled risk difference (RD) is reported with the 95% confidence interval (CI). The review protocol is registered at Prospero (CRD42017080494). Results: A total of 11 cohort studies involving 21,838 patients were included. Studies differed in imaging, their surveillance protocols, and definitions of compliance subgroups. Median follow-up was 31.7 months (interquartile range 29.8, 49.3). The overall reintervention rate was 5%, while the overall mortality was 31%. The RD for the reintervention rate was 4% (95% CI 1% to 7%) in favor of partial/noncompliance [number needed to harm 25 (95% CI 14 to 100)], while mortality showed a nonsignificant RD of 12% (95% CI -2% to 26%) in favor of partial/noncompliance. Two studies reported that 41% to 53% of reinterventions were performed for complications detected through imaging surveillance; the other events were detected through patient symptoms. Conclusion: Patients who are compliant with imaging surveillance appear to undergo more reinterventions than those who are partially or noncompliant. However, imaging surveillance does not seem to protect against mortality. This suggests that the recommended yearly imaging surveillance may not be beneficial for all EVAR patients.

Pathophysiology and treatment of focal segmental glomerulosclerosis: the role of animal models.

Focal segmental glomerulosclerosis (FSGS) is a kidney disease with progressive glomerular scarring and a clinical presentation of nephrotic syndrome. FSGS is a common primary glomerular disorder that causes renal dysfunction which progresses slowly over time to end-stage renal disease. Most cases of FSGS are idiopathic Although kidney transplantation is a potentially curative treatment, 40% of patients have recurrence of FSGS after transplantation. In this review a brief summary of the pathogenesis causing FSGS in humans is given, and a variety of animal models used to study FSGS is discussed. These animal models include the reduction of renal mass by resecting 5/6 of the kidney, reduction of renal mass due to systemic diseases such as hypertension, hyperlipidemia or SLE, drug-induced FSGS using adriamycin, puromycin or streptozotocin, virus-induced FSGS, genetically-induced FSGS such as via Mpv-17 inactivation and α-actinin 4 and podocin knockouts, and a model for circulating permeability factors. In addition, an animal model that spontaneously develops FSGS is discussed. To date, there is no exact understanding of the pathogenesis of idiopathic FSGS, and there is no definite curative treatment. One requirement facilitating FSGS research is an animal model that resembles human FSGS. Most animal models induce secondary forms of FSGS in an acute manner. The ideal animal model for primary FSGS, however, should mimic the human primary form in that it develops spontaneously and has a slow chronic progression. Such models are currently not available. We conclude that there is a need for a better animal model to investigate the pathogenesis and potential treatment options of FSGS.