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Preferences of patients, their family caregivers and vascular surgeons in the choice of abdominal aortic aneurysms treatment options: the PREFER study.
Abstract
Factors influencing the choice between endovascular (endovascular aneurysm repair, EVAR) and open repair (OPEN) of abdominal aortic aneurysm (AAA) are of increasing interest. We quantified their importance among the different subjects involved in the treatment.
Pre- and postoperative patients (pts), their relatives and vascular surgeons completed questionnaires evaluating six treatment characteristics: anaesthesia; recovery time to basic everyday activities; risk of re-intervention at 5 years (RR); complexity of follow-up; risk of major complications; and additional cost of intervention (AC). Through a discrete choice experiment, hypothetical scenarios of treatment were obtained and the relative importance (RI) of each characteristic was determined through a conditional logistic regression model.
A total of 160 pts, 102 relatives and 30 surgeons from nine centres completed the questionnaires. Major complications and re-intervention risk were the most important characteristics (RI = 56.0% and 27.2%, respectively) for all the respondent categories. Pts and their relatives considered very important also a possible out-of-pocket AC. Recovery time and type of anaesthesia were among the least important characteristics, including hospital additional cost for surgeons. The different categories of respondents showed different opinions towards different treatment characteristics depending also on possible previous treatment.
Preferences for AAA treatment characteristics differ between groups of involved subjects. Understanding individuals' preferences could help in optimising treatment benefits.
... The importance of considering patients' preferences when making decisions for treatment has been underlined in the last years and has been the focus of recent research. [17][18][19][20][21][22] The research studies published so far on this topic are different regarding their specific objectives, the methods and instruments used to elicit individuals' preferences, the context where data were collected and subjects involved. However, all the studies agreed on the importance of informing and making the patients aware of all the implications of their conditions and possible treatments, so as to involve them directly in the decision making process for the obtainment of more satisfactory results. ...
... However, all the studies agreed on the importance of informing and making the patients aware of all the implications of their conditions and possible treatments, so as to involve them directly in the decision making process for the obtainment of more satisfactory results. [17][18][19][20][21][22] Some key differences and main results of these studies are summarized below. Landau et al. 17 analyzed the following data from patients with AAA: their willingness to accept, in case they needed surgery in the future, longer travel distances to reach treatment centers that ensure lower perioperative mortality in comparison with local centers. ...
... Type of incision and radiation exposure and the risk of sexual dysfunction were considered less important than the other characteristics. The study conducted in Italy by Faggioli et al. 19 focused on the factors influencing the choice between EVAR and open repair. In this study the participants were patients diagnosed with AAA assigned to, or already treated with, elective EVAR or open surgery, their family caregivers (spouse, children, friends etc.) and their surgeons. ...
... CTA was performed with and without contrast medium during arterial and venous phases using a 1 mm slice thickness. All measurements were performed using a workstation with Diagnostics 2023, 13, 409 3 of 11 dedicated software and center lumen line reconstruction (OsiriX MD software version 12; PIXMEO, Bernex, Switzerland) [16]. ...
... CTA was performed with and without contrast medium during art venous phases using a 1 mm slice thickness. All measurements were performe workstation with dedicated software and center lumen line reconstruction (O software version 12; PIXMEO, Bernex, Switzerland) [16]. ...
Purpose: After endovascular aneurysm repair (EVAR), an increased [18F]FDG uptake may be observed at PET/CT, being common to both vascular graft/endograft infection (VGEI) and sterile post-surgical inflammation. Increased non-specific metabolic activity, due to foreign body reaction, can persist for several years after surgery, thus complicating the interpretation of PET/CT studies. In this paper, we aimed to assess [18F]FDG distribution at different time-points after the implant of abdominal Endurant® endografts in patients without suspicion of infection. Methods: We retrospectively evaluated [18F]FDG/CT in 16 oncological patients who underwent abdominal aortic aneurysm exclusion with Endurant® grafts. Patients had no clinical suspicion of infection and were followed up for at least 24 months after scan. [18F]FDG PET/CT scans were interpreted using both visual and semi-quantitative analyses. Results: The time between the EVAR procedure and [18F]FDG PET/CT ranged between 1 and 36 months. All grafts showed mild and diffuse [18F]FDG uptake without a focal pattern. Mean values of SUVmax were 2.63 ± 0.48 (95% CI 2.38–2.88); for SUVmean 1.90 ± 0.33 (95% CI 1.72–2.08); for T/B ratios 1.43 ± 0.41 (95% CI 1.21–1.65). SUVmax and SUVmean were not correlated to the time elapsed from the procedure, but we observed a declining trend in T/B ratio over time. Conclusions: Endovascular implant of Endurant® grafts does not cause a significant inflammatory reaction. The evidence of faint and diffuse [18F]FDG uptake along the graft can reliably exclude an infection, even in early post-procedural phases. Therefore, in patients with a low probability of VGEI, [18F]FDG PET/CT can also be performed immediately after EVAR.
... It is therefore not possible to provide very detailed recommendations, and important to allow some degree of freedom for individualised decision making, respecting patient choice whenever possible. 194,577 Nearly all the evidence suggests a significant short-term survival benefit for EVAR over OSR, with a similar longterm outcome up to 15 years of follow up. Yet, there are indications that an increased rate of complications may occur after 8e10 years with earlier generation EVAR devices and uncertain durability of current devices, particular the low profile devices. ...
... Level References IIa B [48,70,71,78,100,192,193,194,237,270 5.1.1. Symptomatic non-ruptured AAA. ...
This article describes the ESVS practice guidelines for abdominal aortic and iliac aneurysms.
... Although early applications were used to quantify process utility [9,10], more recent applications have focused on patient preferences for health status [11,12], screening [13], prevention [14,15], pharmaceutical treatment [16,17], therapeutic devices [18,19], diagnostic testing [20,21], and end-of-life care [22,23]. In addition, conjoint analysis methods have been used to study decision making among stakeholders other than patients, including clinicians [24][25][26], caregivers [25,27], and the general public [28,29]. ...
... Although early applications were used to quantify process utility [9,10], more recent applications have focused on patient preferences for health status [11,12], screening [13], prevention [14,15], pharmaceutical treatment [16,17], therapeutic devices [18,19], diagnostic testing [20,21], and end-of-life care [22,23]. In addition, conjoint analysis methods have been used to study decision making among stakeholders other than patients, including clinicians [24][25][26], caregivers [25,27], and the general public [28,29]. ...
Conjoint analysis is a stated-preference survey method that can be used to elicit responses that reveal preferences, priorities, and the relative importance of individual features associated with health care interventions or services. Conjoint analysis methods, particularly discrete choice experiments (DCEs), have been increasingly used to quantify preferences of patients, caregivers, physicians, and other stakeholders. Recent consensus-based guidance on good research practices, including two recent task force reports from the International Society for Pharmacoeconomics and Outcomes Research, has aided in improving the quality of conjoint analyses and DCEs in outcomes research. Nevertheless, uncertainty regarding good research practices for the statistical analysis of data from DCEs persists. There are multiple methods for analyzing DCE data. Understanding the characteristics and appropriate use of different analysis methods is critical to conducting a well-designed DCE study. This report will assist researchers in evaluating and selecting among alternative approaches to conducting statistical analysis of DCE data. We first present a simplistic DCE example and a simple method for using the resulting data. We then present a pedagogical example of a DCE and one of the most common approaches to analyzing data from such a question format—conditional logit. We then describe some common alternative methods for analyzing these data and the strengths and weaknesses of each alternative. We present the ESTIMATE checklist, which includes a list of questions to consider when justifying the choice of analysis method, describing the analysis, and interpreting the results.
... After the paternalistic model in the doctor-patient relationship has been obsoleted, shared decision-making has been recommended. In the modern world, the informative model is mostly used, and the decision-making or to final decision is left to the patient as the main consumer [14,15]. Appropriate decision is based on an average patient's education as an ethical pathway. ...
Aim: Patient awareness and disease-specific knowledge are essential for shared decision-making of patients with abdominal aortic aneurysms. With this pilot survey, we aimed to figure out the obstacles to patient's awareness about the aortic aneurysm before and after the procedure. Material and Methods: Patients who experienced elective endovascular aortic aneurysm repair (EVAR) in our Cardiovascular Surgery Clinic between 2019 to 2023 were the selected patient cohort. The first 50 patients who visited our outpatient clinic were given a questionnaire about their awareness of the aneurysm disease, disease-specific knowledge, and the comprehensibility of the patient information provided before and after the procedure. Results: The mean age of our patients was 66±6.9. Younger patients were more aware of the situation before the information (p=0.013). Patients anxious about the disease were also more conscious about the aortic aneurysm (p=0.02). Although all patients were given preoperative information and disease-specific information by the same team, 13 patients (26%) could not recall anything about the disease and did not recall what operation was performed and why. Thirty-seven patients (74%) gained awareness about the disease. The patients with at least an educational level above high school gained more awareness than others (p=0.04). Conclusion: The Classical informatory model seems insufficient for gaining awareness and consciousness for older patients and with patients with low level of education. Strengthened patient-practitioner interaction with supplemental technologies (leaflets, interactive media, audio tapes, etc.) may improve these patients' shared decision-making. More prospective research is required in this regard.
... Indication for AAA repair was based primarily on aneurysm diameter; rate of growth more than 1 cm/year and aortic wall morphology were also considered [13]. In both centers, indications for EVAR were based on age, comorbidities, operators' experience, and patient preferences [14]. Prior to initial EVAR procedure, all patients underwent an extensive assessment, including clinical history reporting, physical examination, chest radiography, electrocardiography, pulmonary function testing, transthoracic echocardiography, and laboratory testing. ...
Introduction:
The aim of the present study is to report the outcome of patients presenting an isolated type II endoleak (TIIEL) requiring reintervention and to identify clinical and anatomical characteristics potentially implicated in refractory TIIEL occurrence and fate.
Materials and methods:
A multicenter retrospective study on TIIEL requiring reintervention was conducted between January 2003 and December 2020. Demographic and clinical characteristics, procedural technical aspects, reinterventions, and outcomes were recorded. TIIEL determining sac expansion greater than 10 mm underwent a further endovascular procedure aiming to exclude aneurismal sac. Redo endovascular procedures were performed via endoleak nidus direct embolization and/or aortic side branches occlusion. TIIELs responsible for persisting aneurysmal sac perfusion 6 months after redo endovascular procedures were classified as "refractory" and submitted to open conversion.
Results:
A total of 102 TIIEL requiring reintervention were included in the final analysis. Eighty-eight (86.27%) patients were male, the mean age was 77.32 ± 8.08 years, and in 72.55% of cases the American Society of Anaesthesiologists (ASA) class was ≥3. The mean aortic diameter was 64.7 ± 14.02 mm, half of treated patients had a patent inferior mesenteric artery (IMA), and 44.11% ≥ 3 couples of patent lumbar arteries (LA). In 49 cases (48.03%) standard endovascular aneurysm repair (EVAR) procedure was completed without adjunctive maneuvers. All enrolled patients were initially submitted to a further endovascular procedure once TIIEL requiring reintervention was diagnosed; 57 patients underwent LAs or IMA embolization (55.87%), 42 transarterial aneurismal sac embolization (41.17%), and three (2.96%) laparoscopic ostial ligations of the inferior mesenteric artery. During a mean follow-up of 15.22 ± 7.57 months (7-48), a redo endovascular approach was able to ensure complete sac exclusion in 52 cases, while 50 patients presented a still evident refractory TIIEL and therefore a surgical conversion or semiconversion was conducted. At the univariate analysis refractory TIIEL patients were significantly different from those who did not develop the complication in terms of preoperative clinical, morphological characteristics, and initial EVAR procedures: coronary artery disease occurrence (p = 0.005, OR: 3.18, CI95%: 1.3-7.2); preoperative abdominal aortic aneurysm (AAA) sac diameter (p = 0.0055); IMA patency (p = 0.016, OR: 2.64, CI95%: 1.18-5.90); three or more patent LAs; isolated standard EVAR without adjunctive procedures (p > 0.0001; OR: 9.48, CI95%: 3.84-23.4).
Conclusions:
Our experience seems to demonstrate that it is reasonable to try to preoperatively identify those patients who will develop a refractory TIIEL after EVAR and those with a TIIEL requiring reintervention for whom a simple endovascular redo will not be enough, needing surgical conversion.
... Similar conclusions are drawn from the qualitative PREFER study (Preferences of Patients, Their Family Caregivers and Vascular Surgeons in the Choice of Abdominal Aortic Aneurysms Treatment Options), which explored patients' motivations to decide on EVAR or OR. 67,68 In the current study, it was found that patients and caregivers were not concerned about a more intense follow up. Therefore, the general notion that intensive mandatory follow up negatively impact QoL is not correct. ...
Objective
In order to better incorporate the patient’s perspective in medical decision making, core outcome sets (COS) are being defined. In the field of abdominal aortic aneurysm (AAA), efforts to capture the patient’s perspective focus on generic quantitative quality of life (QoL) scales. The question arises whether these quantitative scales adequately reflect the patient’s perspective on QoL, and whether they can be included in the QoL aspect of COS. A scoping review of QoL assessment in the context of elective AAA repair was undertaken.
Data Sources
PubMed, Embase, Web of Science, and the Cochrane Library.
Review Methods
A scoping review was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews (PRISMA-ScR) guidelines. Articles reporting QoL assessment in the context of elective AAA repair were identified. Quantitative studies (i.e., traditional QoL scales) were aligned (triangulation approach) with qualitative studies (i.e., patient perspective) to identify parallels and discrepancies. Mean Short Form 36 item survey (SF-36) scores were pooled using a random effects model to evaluate sensitivity to change.
Results
Thirty-three studies were identified, of which 29 (88%) were quantitative and four (12%) qualitative. The 33 studies reported a total of 54 quantitative QoL scales; the most frequently used were the generic SF-36 (16 studies) and five dimension EuroQol (EQ-5D; eight studies). Aneurysm specific scales were reported by one study. The generic quantitative scales showed poor alignment with the patient’s perspective. The aneurysm specific scales better aligned but missed “concerns regarding symptoms” and “the impact of possible outcomes/complications”. “Self control and decision making”, which was brought forward by patients in qualitative studies, was not captured in any of the current scales.
Conclusion
There is no established tool that fully captures all aspects of the patient’s perspective appropriate for a COS for elective AAA repair. In order to fulfil the need for a COS for the management of, AAA disease, a more comprehensive overview of the patient’s perspective is required.
... 18 Patients have a preference for EVAR because of the 76 lower procedural risk and are less worried by the need for surveillance or secondary interventions. 19 In 77 current vascular surgery practice the role of shared decision making is becoming more important 20 , 78 and detailed information regarding secondary interventions is helpful to make a choice. Probably, the 79 use of decision aids may also help to better align patient's preference. ...
Objectives
Early morbidity and mortality are low after endovascular abdominal aneurysm repair (EVAR), but secondary interventions and late complications are common. The aim of the present multicentre cohort study is to detail the frequency and indication for interventions after EVAR and the impact on long-term survival.
Methods
Retrospective multicentre cohort study of secondary interventions after elective EVAR for an infrarenal abdominal aortic aneurysm (AAA). Consecutive patients (n=349) undergoing EVAR between January 2007 and January 2012 were analysed, with long-term follow-up until December 2018. Those requiring intervention were classified according to the indications and specific nature of the intervention and treatment. The primary study endpoint was overall survival classified for patients with and without intervention. Kaplan-Meier analysis was used to estimate overall survival for those who did and who did not undergo secondary interventions. Univariable and multivariable Cox regression were performed to identify independent variables associated with mortality.
Results
Some 56 patients (16%) underwent 72 secondary interventions after EVAR during a median (IQR) follow-up period of 53.2 months (60.1). Some 45 patients (80.4%) underwent one intervention. Indications for intervention included mainly endograft kinking/outflow obstruction and type II endoleak. An endovascular technique was used in 40.3% of interventions. Median time to secondary intervention was 24.1 months. In 93 patients with abnormalities on imaging, no intervention was performed mainly because the abnormality had disappeared on follow-up imaging (43%). Kaplan-Meier curves showed no difference in survival for patients with and without secondary interventions (p = 0.153). Age (hazard ratio [HR] 1.089, 95% confidence interval [CI] 1.063-1.116), ASA classification (ASA III,IV HR 1.517, 95% CI 1.056-2.178) were significantly related to mortality.
Conclusions
Secondary interventions rates are still considerable after EVAR. Endograft kinking/outflow obstruction and endoleak type II are the most common indications for a secondary intervention. Secondary interventions did not adversely affect long-term overall survival after EVAR.
... It was reported that most the relative importance, possible inuence of cost, and the attitude of the different subjects taking in the treatment other than patients like surgeons and patients relatives have not been analysed. (12) In this context, the present study carries signicance. ...
Introduction: Caregivers face multiple problems while caring. In the process of caregiving, burden was reported to be highest. Objectives: To assess the burden among caregivers of persons with aneurism. Methods: The study adopted descriptive research design. The study participants were recruited with the help of purposive sampling method and predetermined inclusion and exclusion criteria. The participant's age was found to be 38.87 ± 14.28 years. The caregivers of aneurism survivors had experienced severe burden in the Results: domains of nancial burden (04.97±1.80), disruption of routine family activities (3.75±2.02), disruption of family leisure activities (3.07±1.71), and disruption in family interaction (2.62±1.51). Conclusion: Addressing psycho social and emotional needs would bring down the burden of care givers during hospitalization and also follow up.
... Others emphasized using public utilities in economic evaluations to ensure the applicability to more general allocation decisions. The issue of public versus patient preferences in health economic evaluations remains a pressing issue of debate (Faggioli et al., 2011;FDA, 2016). ...
Objectives: Patient preference information (PPI) is gaining recognition among the pharmaceutical industry, regulatory authorities, and health technology assessment (HTA) bodies/payers for use in assessments and decision-making along the medical product lifecycle (MPLC). This study aimed to identify factors and situations that influence the value of patient preference studies (PPS) in decision-making along the MPLC according to different stakeholders.
Methods: Semi-structured interviews (n = 143) were conducted with six different stakeholder groups (physicians, academics, industry representatives, regulators, HTA/payer representatives, and a combined group of patients, caregivers, and patient representatives) from seven European countries (the United Kingdom, Sweden, Italy, Romania, Germany, France, and the Netherlands) and the United States. Framework analysis was performed using NVivo 11 software.
Results: Fifteen factors affecting the value of PPS in the MPLC were identified. These are related to: study organization (expertise, financial resources, study duration, ethics and good practices, patient centeredness), study design (examining patient and/or other preferences, ensuring representativeness, matching method to research question, matching method to MPLC stage, validity and reliability, cognitive burden, patient education, attribute development), and study conduct (patients’ ability/willingness to participate and preference heterogeneity). Three types of situations affecting the use of PPS results were identified (stakeholder acceptance, market situations, and clinical situations).
Conclusion: The factors and situation types affecting the value of PPS, as identified in this study, need to be considered when designing and conducting PPS in order to promote the integration of PPI into decision-making along the MPLC.
... 2 However, patient preference for a minimally invasive procedure with lower peri-operative risk has clearly pushed the broad application of EVAR internationally, despite the lack of convincing health economic cost-effectiveness. 3 Para-/juxtarenal and thoraco-abdominal aortic aneurysms (TAAA) are clearly more challenging to manage, irrespective of the surgical technique used for their treatment. Various complex endovascular techniques for treatment of these aneurysms have been developed over the years, 4,5 with the most established method being use of custom made fenestrated and branched endografts. ...
... 15 In such preferencesensitive treatment decisions, the weighing of harms and benefits depends on the patients' individual preferences. 16 Patient involvement is therefore fundamental in making a decision about which treatment option best fits the patient's situation, goals and values. Nevertheless, patient involvement in treatment decisionmaking is not yet common practice in the field of vascular surgery. ...
Objectives
Shared decision-making (SDM) has been advocated as the preferred method of choosing a suitable treatment option. However, patient involvement in treatment decision-making is not yet common practice in the field of vascular surgery. The aim of this mixed-methods study was to explore patients' decision-making preferences and to investigate which facilitators and barriers patients perceive as important for the application of SDM in vascular surgery.
Design and setting
Patients were invited to participate after visiting the vascular surgical outpatient clinic of an Academic Medical Center in the Netherlands. A treatment decision was made during the consultation for an abdominal aortic aneurysm or peripheral arterial occlusive disease. Patients filled in a number of questionnaires (quantitative part) and a random subgroup of patients participated in an in-depth interview (qualitative part).
Results
A total of 67 patients participated in this study. 58 per cent of them (n=39) indicated that they preferred a shared role in decision-making. In more than half of the patients (55%; n=37) their preferred role was in disagreement with what they had experienced. 31 per cent of the patients (n=21) preferred a more active role in the decision-making process than they had experienced. Patients indicated a good patient–doctor relationship as an important facilitator for the application of SDM.
Conclusions
The vast majority of vascular surgical patients preferred, but did not experience a shared role in the decision-making process, although the concept of SDM was insufficiently clear to some patients. This emphasises the importance of explaining the concept of SDM and implementing it in the clinical encounter.
... Differences in the meaning of disability and optimal recovery have been identified between patients with acute onset activity limitations and clinicians 11 , and between care recipients, relatives and nurses in relation to the quality of care of older people 17 . In a related area, patients and caregivers considered different factors than clinicians when making decisions about the most appropriate procedure for treatment of abdominal aneurysms 18 . Understanding of different perceptions in relation to outcomes is particularly important in trauma where patients may not be able to participate in decision making for some of their hospitalisation. ...
Introduction:
A focus on what is important to patients has been recognized as an essential pillar in care to ensure safe patient care that focuses on outcomes identified as important by patients. Despite this, asking trauma patients and their families what they consider should be the priorities of care and recovery has been neglected.
Methods:
Adult trauma patients admitted to two centers in Australia for ≥24h for the treatment of physical injury, and family members of injured patients and clinicians caring for injured patients were invited to participate. Individual interviews were conducted with the patient and family members prior to hospital discharge, and again one and three months post discharge. Individual interviews or focus groups were conducted with clinicians at one point in time. Content analysis of all transcripts was undertaken to determine the indicators of successful recovery over time.
Results:
Participants in the three stakeholder groups were enrolled (patients - 33; family members-22; clinicians-40). Indicators of recovery focused on five main categories including returning to work, resuming family roles, achieving independence, recapturing normality and achieving comfort. Other categories that were less frequently identified included maintaining one's household, restoring emotional stability, cosmetic considerations and appearance, realignment of life goals, psychological recovery and development of self. Indicators of recovery after physical injury were similar across the three stakeholder groups, although with greater detail identified by patients. In addition, indicators evolved over time with increasing recognition of the importance of the overall impact of the injury in general and on activities of daily living and an unfolding appreciation that life could not be taken for granted.
Conclusions:
Description of the indicators of recovery after traumatic injury that matter to patients, family members and clinicians enable an understanding of similarities and differences. Further testing in a broader cohort of participants is essential to identify patient reported outcome measures that might be used in trauma care and associated research.
... The outputs from DCEs can be used to improve the decision about policy making [29,30], including estimates of the relative importance of each of the attributes, and this allows the policy-maker to observe the impact of each attribute on the overall benefit [31][32][33][34][35][36]. In this study, we mainly focus on the prioritization of attributes for P4P design, and hence, we will present the relative importance of each of the attributes to observe how physicians weigh the magnitude of investment and other favored features associated with a P4P design. ...
Objective
To determine whether the magnitude of incentives or other design attributes should be prioritized and the most important attributes, according to physicians, of the diabetes P4P (pay-for-performance) program design.
Design
We implemented a discrete choice experiment (DCE) to elicit the P4P incentive design-related preferences of physicians.
Participants
All of the physicians (n = 248) who participated in the diabetes P4P program located in the supervisory area of the northern regional branch of the Bureau of National Health Insurance in 2009 were included. The response rate was ∼60%.
Results
Our research found that the bonus type of incentive was the most important attribute, followed by the incentive structure and the investment magnitude.
Conclusions
Physicians may feel that good P4P designs are more important than the magnitude of the investment by the insurer. The two most important P4P designs include providing the bonus type of incentive and using pay-for-excellence plus pay-for-improvement.
... A single-center retrospective study was conducted using a prospectively collected database between January 2008 and December 2013 with the aim of assessing whether maximum AAA diameter, thrombus amount, or aneurysm volume represented significant predictors of adverse outcome after standard EVAR using commercially available stent graft systems. Indications for EVAR were based on age, comorbidities, experience of the center, and patient preferences (13). Ethical approval was obtained by the institutional review board. ...
To evaluate the impact of two-dimensional and three-dimensional preoperative morphologic features analyzed on computed tomography (CT) angiography on midterm outcome in patients with abdominal aortic aneurysms (AAAs) treated with endovascular aneurysm repair (EVAR).
A retrospective analysis was conducted using a prospectively collected database. Morphologic features considered as potentially influencing outcomes were maximum aortic diameter, thrombus area, overall aneurysm volume, and intrasac thrombus volume. Outcome measures were all perioperative and midterm AAA-related reinterventions and all-cause mortality.
Investigators reviewed 191 preoperative CT angiography scans. Mean maximum aortic diameter was 58 mm; thrombus area, 49.6%; aortic volume, 159.36 cm(3); and thrombus volume, 58.6%. Technical success was achieved in all cases. No reintervention was required in the perioperative period, and there was no perioperative mortality. At a mean follow-up of 32 months ± 16.8 (range, 3-66 mo), mortality rate was 9.4%, AAA-related death was 0, and reintervention rate was 8.9%. Causes of reintervention included type I endoleak (n = 3 [1.6%]), type II endoleak (n = 7 [3.7%]), type III endoleak (n = 1 [0.5%]), endograft limb thrombosis (n = 4 [2.1%]), and access vessel thrombosis (n = 2; 1%). Greater thrombus area (> 60%) and thrombus volume (> 59%) were predictors for reintervention (P = .005 and P = .0034). Greater maximum aortic diameter (> 59 mm) and aortic volume (> 159 cm(3)) were related to higher reintervention rate without statistical significance (P = .62 and P = .12). Aortic volume was a predictor of any adverse event, reintervention, and all-cause mortality after EVAR (P = .03).
Thrombus area and volume are related to higher rates of reintervention. Maximum aortic diameter was related to a higher reintervention rate, but this was not significant.
Copyright © 2015 SIR. Published by Elsevier Inc. All rights reserved.
... An association of FMD has been observed with other arterial diseases such as Marfan syndrome, Takayasu arteritis, neurofibromatosis type I, and Ehlers-Danlos syndrome type IV (vascular type). 3,4 Did the authors suspect any possible different etiology of renal artery stenosis (vasculitis, collagenopathies)? Were other sites of arterial disease excluded in the patient? ...
... Information on health-related quality of life (HRQOL) and quality-adjusted life years (QALYs) is increasingly being taken into consideration to support the decision-making process regarding the utilization of available resources in Italy [2][3][4]. In the last few years, the EuroQol five-dimensional (EQ-5D) questionnaire has being recognized and used in the Italian health care system for its abilities to easily describe, measure, and value individuals' health in several health care sectors [5][6][7][8][9][10][11][12]. ...
To estimate a value set for the calculation of Italian-specific quality-adjusted life years (QALYs), based on preferences elicited on EuroQol five-dimensional (EQ-5D) questionnaire health states using the time trade-off technique.
The revised standard Measurement and Valuation of Health protocol was followed. Twenty-five health states, divided into three groups and given to 450 subjects, were selected to obtain 300 observations per state. Subjects aged 18 to 75 years were recruited to be representative of the Italian general adult population for age, sex, and geographical distribution. To improve efficiency, face-to-face interviews were conducted by using the Computer Assisted Personal Interviewing approach. Several random effects regression models were tested to predict the full set of EQ-5D questionnaire health states. Model selection was based on logical consistency of the estimates, sign and magnitude of the regression coefficients, goodness of fit, and parsimony.
The model that satisfied the criteria of logical consistency and was more efficient includes 10 main effect dummy variables for the EQ-5D questionnaire domain levels and the D1 interaction term, which accounts for the number of dimensions at levels 2 or 3 beyond the first. This model has an R(2) of 0.389 and a mean absolute error of 0.03, which are comparable to or better than those of models used in other countries. The utility estimates after state 11111 range from 0.92 (21111) to -0.38 (33333). Italian utility estimates are higher than those estimated in the United Kingdom and Spain and used so far to assess QALYs and conduct cost-utility evaluations in Italy.
A specific value set is now available to calculate QALYs for the conduction of health economic studies targeted at the Italian health care system.
Objectives:
Misinterpretation of patient preferences in perioperative education can lead to an undesired treatment decision. This explorative interview study presents differences in perspectives of patients and professionals on patient education in complex endovascular aortic aneurysm management.
Methods:
Using convenience sampling, a cross-sectional interview study was performed among patients who were in various stages of the decision-making process for complex endovascular aortic repair. Five physicians were interviewed, representing the main providers of clinical information. Interviews were transcribed verbatim and analyzed inductively.
Results:
Twelve patients (mean age 76.6 (SD: 6.4), 83% male) were interviewed. Ten (83%) felt like they had no other realistic option besides undergoing surgery, whereas all professionals (5/5) stressed the importance of delicate patient selection. Five patients out of 10 (50%) who commented on their preferred decisional role, considered the professional's advice as decisive. All but one patient (11/12) reported that the information was easy to understand, whereas four out of five professionals (80%) doubted whether patients could fully comprehend everything. Patients experienced a lack of information on the recovery process, although professionals stated that this was addressed during consultation.
Conclusions:
Several differences were found in the perspective of patients and professionals on education in complex aortic aneurysm management. In order to optimize patient involvement in decision-making, professionals should be aware of these possible discrepancies and address them during consultation. Future research could focus on these differences in more detail, by including more patients depending on their treatment- and decision stage.
Importance:
Patients with abdominal aortic aneurysm (AAA) can choose open repair or endovascular repair (EVAR). While EVAR is less invasive, it requires lifelong surveillance and more frequent aneurysm-related reinterventions than open repair. A decision aid may help patients receive their preferred type of AAA repair.
Objective:
To determine the effect of a decision aid on agreement between patient preference for AAA repair type and the repair type they receive.
Design, setting, and participants:
In this cluster randomized trial, 235 patients were randomized at 22 VA vascular surgery clinics. All patients had AAAs greater than 5.0 cm in diameter and were candidates for both open repair and EVAR. Data were collected from August 2017 to December 2020, and data were analyzed from December 2020 to June 2021.
Interventions:
Presurgical consultation using a decision aid vs usual care.
Main outcomes and measures:
The primary outcome was the proportion of patients who had agreement between their preference and their repair type, measured using χ2 analyses, κ statistics, and adjusted odds ratios.
Results:
Of 235 included patients, 234 (99.6%) were male, and the mean (SD) age was 73 (5.9) years. A total of 126 patients were enrolled in the decision aid group, and 109 were enrolled in the control group. Within 2 years after enrollment, 192 (81.7%) underwent repair. Patients were similar between the decision aid and control groups by age, sex, aneurysm size, iliac artery involvement, and Charlson Comorbidity Index score. Patients preferred EVAR over open repair in both groups (96 of 122 [79%] in the decision aid group; 81 of 106 [76%] in the control group; P = .60). Patients in the decision aid group were more likely to receive their preferred repair type than patients in the control group (95% agreement [93 of 98] vs 86% agreement [81 of 94]; P = .03), and κ statistics were higher in the decision aid group (κ = 0.78; 95% CI, 0.60-0.95) compared with the control group (κ = 0.53; 95% CI, 0.32-0.74). Adjusted models confirmed this association (odds ratio of agreement in the decision aid group relative to control group, 2.93; 95% CI, 1.10-7.70).
Conclusions and relevance:
Patients exposed to a decision aid were more likely to receive their preferred AAA repair type, suggesting that decision aids can help better align patient preferences and treatments in major cardiovascular procedures.
Trial registration:
ClinicalTrials.gov Identifier: NCT03115346.
Background:
For various vascular surgical disorders different treatment options are available and feasible. Hence, vascular surgery seems an area par excellence for shared decision-making (SDM), in which clinicians incorporate patients' preferences into the final treatment decision. However, current SDM-levels in vascular surgical outpatient clinics is below expectations. To improve this, different decision support tools (DSTs) were 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, a training on how to apply SDM during the clinician-patient encounter was used in this study. Data were obtained via questionnaires and audio-recordings. 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:
We included 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 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 AAA-patients and doubled (16.0% to 32.0%) among IC-patients. 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 for improving SDM.
Trial registration:
NTR6487.
An abdominal aortic aneurysm (AAA) is often asymptomatic until complications such as rupture occur. Prevalence in those aged 50–84 years is 1.4% in the USA. Typically, AAAs are incidentally detected during imaging for other disorders. Risk factors include old age, male gender, and smoking; there is an association with vascular disorders, hypertension, and hyperlipidemia. Once diagnosed, an AAA requires regular surveillance through imaging. Medical management includes addressing the risk factors, control of hypertension and hyperlipidemia, smoking cessation, and watchful waiting with surveillance. Elective surgery is recommended for aneurysms that continue to enlarge during surveillance or are larger than 5.5 cm. In the event of rupture, mortality is high in spite of emergency surgery. The USPSTF recommendation is for a onetime ultrasonographic screening for AAA in males aged 65 or older; this is associated with decreased AAA rupture and AAA-related mortality rates but with no effect on all-cause mortality rates. Ultrasonography is the preferred imaging modality for screening and surveillance; it has high sensitivity and specificity; in the event of suspected rupture or bleeding, a CT scan or MRI becomes the modality choice for imaging. Risk factors that are modifiable should be addressed. Surgical approaches include endovascular aortic aneurysm repair and open surgical repair; endovascular approach offers better outcomes in terms of morbidity and mortality.
Background:
Operative mortality after endovascular aneurysm repair (EVAR) has been reported as lower than open surgical repair (OSR) for abdominal aortic aneurysm (AAA) in randomized controlled trials. However, many cohort studies have demonstrated similar mortality rates for both procedures. We compared operative mortality between EVAR and OSR, at our institution.
Methods:
All AAA operations from 2012 to 2017 were reviewed, and baseline characteristics were collected. Outcomes included 30-day mortality, operative data, complications, length of hospital stay (LOS), costs, re-intervention, and survival rates were compared. A multivariable analysis with unbalanced characteristics was performed.
Results:
We had a total of 162 patients, 100 having OSR and 62 for EVAR. The EVAR group was older, with higher ASA classification. Thirty-day mortality rate did not significantly differ (0/100 for OSR and 2/62 (3%) for EVAR; p = 0.145), while the EVAR group had less blood loss, shorter operative times, and LOS, but higher re-intervention rates (adjusted hazard ratio 6.4 (95%CI: 1.4, 26.8)). Survival rates did not significantly differ between the groups. EVAR cost approximately 1-million yen more.
Conclusions:
OSR had low 30-day mortality rate in selected low-risk patients whereas EVAR had less blood loss, shorter operative times, LOS and could be done in high-risk patients with low 30-day mortality but with higher re-intervention rate.
Purpose
to evaluate the impact of bi- and three-dimensional preoperative aortic morphological features and their immediate postoperative variations on the outcome of abdominal aortic aneurysms (AAA) treated by endovascular exclusion with standard devices (EVAR).
Materials and Methods
Double center retrospective analysis of prospectively collected registry data of EVAR patients. For all patients, preoperative and 30-day computed tomographic angiography images (CTA) were reviewed. Preoperative maximum AAA diameter >59mm and volume >159cm³, and any 30-day postoperative increasing at CTA, were considered as potentially influencing the outcome. The outcome measures were: primary technical success; 30-day, 1-year, and mean follow-up reintervention, all-cause and AAA-related mortality rates, and also endoleak-related reinterventions.
Results
333 patients were enrolled. Mean preoperative and 30-day AAA diameter and volume were 50.4mm±11.8 vs. 49.1mm±12.1, and 112.9cm3±79.5 vs. 112.1cm3±80.5, respectively. Primary technical success was achieved in all cases. At 34.9 months follow-up, cumulative reintervention rate was 12.0%, mortality rates 7.2%, without AAA-related deaths. Endoleak-related reintervention rate was 7.5%. At uni- and multi-variate analysis, preoperative AAA diameter >59mm, and AAA volume >159cm³ were significantly associated to reintervention (p=0.012; p=0.002), and reintervention and death (p=0.002; p=0.001) during follow-up. Additionally, any increase in postoperative AAA diameter or volume was significantly associated with reintervention (p=0.001, p=0.001) and reintervention and death (p=0.006, p=0.001). Endoleak-related reintervention were also significantly associated with all of the analysed morphological parameters (p=0.019, p=0.005, p=0.005, and p=0.002, respectively).
Conclusions
Patients with larger baseline AAA size and volume as well as unfavourable early remodelling of the sac are associated to worse long-term EVAR outcome.
Purpose
The aim of this study was to compare early and long-term outcomes of EVAR vs. open repair (OSR) in patients < 65-year.
Methods
Data of patients < 65 years undergoing infra-renal AAA repair, between 2005 and 2013, were retrospectively reviewed. All EVAR procedures were performed according to the instruction for use, and only OSR procedures with an infra-renal aortic cross clamping were included in the study.
Results
In this group of 115 patients, (EVAR: 58 patients, 51%; OSR: 57 patients, 49%), EVAR and OSR patients had similar comorbidities, except for obesity (EVAR:38% vs OSR:19%, p=.03). A stay in intensive care unit (ICU) was necessary in 19% of patients with EVAR vs 79% with OSR (p=.001) and the amount of blood transfusion was 236+31mL for EVAR vs 744+98mL for OSR (p=.001). Hospital stay was 4+2 days for EVAR vs 9+6 days for OSR (p=.03). The overall 30-day mortality was 1% (EVAR:0% vs OSR:2%; p=.30). Five patients (4%) required reinterventions within 30-day (EVAR:0% vs OSR: 8%; p=.001). The mean follow-up was 86+38months. Freedom from reintervention at 10 years following EVAR was 81% vs OSR 74%; (p=.77). Late reinterventions were reported in 13 OSR patients (23%) and in 10 EVAR patients (17%). Postoperative retrograde ejaculation occurred more often in patients with OSR (31%) vs EVAR (2%) (p=.001). During follow-up, cancer was found in 19 (17%) patients with no difference between EVAR and OSR (p=.83). Global survival at 10 years was 72% (EVAR: 79% vs. OSR: 70%; p=0.94).
Conclusion
In this study, EVAR was associated with a shorter hospital stay, less need for ICU, and less early reinterventions compared to OSR. Survival and reinterventions during follow-up were not significantly different between EVAR and OSR. According to these results, EVAR may be considered for patients <65 years with a favourable anatomy.
Background:
Patients express strong opinion over discharge destination-preferring discharge home versus elsewhere. As focus on patient satisfaction increases, we sought to understand differences in postoperative discharge destination after minimally invasive versus open anatomic lung resection for lung cancer to guide patient education and management, and to better understand the postoperative patient experience.
Methods:
Procedures were identified by current procedural terminology and international classification of disease codes using the 2012-17 American College of Surgeons National Surgical Quality Improvement Program dataset. Propensity score analysis was used to assess the relationship between surgical approach and nonhome discharge destination (primary outcome), and postoperative complications, related unplanned readmission, and mortality (secondary outcomes).
Results:
A total of 17,303 patients underwent anatomic lung resection for lung cancer including 10,121 (58.5%) minimally invasive and 7,182 (41.5%) open resections. Open resection patients had 60% greater odds of nonhome discharge (p<0.0001), 58% greater odds of postoperative mortality (p=0.003), 36% greater odds of postoperative complication (p<0.0001), and 17% greater odds of readmission (p=0.04) compared to minimally invasive patients.
Conclusions:
The minimally invasive approach to lung resection for lung cancer offers patients a more desirable patient-centered postoperative experience as well as more favorable clinical outcomes, and should be favored when feasible.
Background
There is a paucity of data guiding preoperative counseling on the need for discharge to a facility or nonhome discharge (NHD) following elective endovascular repair of abdominal aortic aneurysms (endovascular aneurysm repair [EVAR]). This study seeks to determine the preoperative predictors of NHD following EVAR in baseline home-dwelling patients and to determine whether NHD is associated with major postdischarge complications and readmission.
Methods
This retrospective cohort study utilized the National Surgical Quality Improvement Program Vascular Procedure Targeted database to identify elective EVAR cases admitted from home (2011 to 2015). The primary end point was NHD. A multivariable logistic regression model was used to determine predictive preoperative factors for NHD and to determine whether NHD predicted major postdischarge complications and readmission.
Results
Overall 6,276 cases were included; 291 (4.6%) required NHD. NHD were more frequently female, anemic, functionally dependent, nonsmokers, had chronic obstructive pulmonary disease, recent congestive heart failure exacerbation, and open baseline wounds. NHD was associated with complex surgery, indicated by operative time more than the median, 2.5 hr. Significant predictors for NHD on multivariable analysis included female sex (odds ratio [OR]: 2.2, confidence interval [CI]: 1.7–2.9, P < 0.001), octogenarians (OR: 5.7 CI: 2.3–14.1; P < 0.001) and nonagenarians (OR: 14.6, CI: 5.4–39.2; P < 0.001), dependent functional status (OR: 5.4, CI: 3.3–8.8; P < 0.001), preoperative open wound (OR: 3.5, CI: 1.4–8.9; P = 0.006), high operative time (OR: 2.7, CI: 2.0–3.6; P < 0.001), and hypogastric embolization (OR: 1.6, CI: 1.1–2.1 P = 0.022), C-statistic = 0.780. On adjusted analysis, NHD did not independently predict major postdischarge complication (OR: 1.0 CI: 0.6–1.9; P = 0.875) or unplanned readmission (OR 1.0, CI: 0.6–1.5, P = 0.842).
Conclusions
Discharge to skilled facility following EVAR can be predicted using preoperative factors. Future studies should seek to validate these findings in a prospective manner. Identifying high-risk patients' NHD can help define expectations and facilitate early referral to skilled facilities that may reduce hospital length of stay, reducing health-care costs.
Industry, regulators, health technology assessment (HTA) bodies, and payers are exploring the use of patient preferences in their decision-making processes. In general, experience in conducting and assessing patient preference studies is limited. Here, we performed a systematic literature search and review to identify factors and situations influencing the value of patient preference studies, as well as applications throughout the medical product lifecyle. Factors and situations identified in 113 publications related to the organization, design, and conduct of studies, and to communication and use of results. Although current use of patient preferences is limited, we identified possible applications in discovery, clinical development, marketing authorization, HTA, and postmarketing phases.
Objectives
To review studies eliciting patient and healthcare provider preferences for healthcare interventions using discrete choice experiments (DCEs) to (1) review the methodology to evaluate similarities, differences, rigour of designs and whether comparisons are made at the aggregate level or account for individual heterogeneity; and (2) quantify the extent to which they demonstrate concordance of patient and healthcare provider preferences.
Methods
A systematic review searching Medline, EMBASE, Econlit, PsycINFO and Web of Science for DCEs using patient and healthcare providers. Inclusion criteria: peer-reviewed; complete empiric text in English from 1995 to 31July 2015; discussing a healthcare-related topic; DCE methodology; comparing patients and healthcare providers.
Design
Systematic review.
Results
We identified 38 papers exploring 16 interventions in 26 diseases/indications. Methods to analyse results, determine concordance between patient and physician values, and explore heterogeneity varied considerably between studies. The majority of studies we reviewed found more evidence of mixed concordance and discordance (n=28) or discordance of patient and healthcare provider preferences (n=12) than of concordant preferences (n=4). A synthesis of concordance suggested that healthcare providers rank structure and outcome attributes more highly than patients, while patients rank process attributes more highly than healthcare providers.
Conclusions
Discordant patient and healthcare provider preferences for different attributes of healthcare interventions are common. Concordance varies according to whether attributes are processes, structures or outcomes, and therefore determining preference concordance should consider all aspects jointly and not a binary outcome. DCE studies provide excellent opportunities to assess value concordance between patients and providers, but assessment of concordance was limited by a lack of consistency in the approaches used and consideration of heterogeneity of preferences. Future DCEs assessing concordance should fully report the framing of the questions and investigate the heterogeneity of preferences within groups and how these compare.
Introduction
The aim of this review is to assess if late mortality after endovascular repair (EVAR) of abdominal aortic aneurysms (AAA) is a real problem, and whether it could be an issue in the case of medical litigation.
Material and Methods
a review of all English language literature was performed on PubMed web-site, looking for all papers reporting EVAR long-term mortality rate. EVAR performances were reviewed also from an ethical and medico-legal point of view, based on current Italian laws.
Results
mono-centric studies, and international registers suggest that today EVAR offers similar (if not better) results than open repair (OR) in the treatment of AAAs with standard and complex anatomies, even if performed outside the devices-specific instructions for use. In contrast, large randomized trials, and consequently current guidelines, suggest that EVAR still has an ancillary role compared to OR, only to be used for highly selected patients.
Recently, specific litigation cases on surgical options related to the treatment of aortic aneurysms has developed. The informed consent process needs to include not only mortality and major complications related to the procedure but also the chance of patients’ outcomes. For those reasons, the generic nature of informed consent has been criticized.
Conclusions
No conclusive data is currently available to assess the initial question of late mortality after EVAR but results are still improving. In the meantime, widespread use of EVAR as first choice for treating AAA may only be acceptable in high-volume centres validating their results by a strict follow up protocol.
Abdominal aortic aneurysm (AAA) is often asymptomatic until complications such as rupture occur. AAAs are often incidentally detected during imaging for other disorders. Risk factors include old age, male gender, and smoking; there is an association with vascular disorders, hypertension, and hyperlipidemia. Once diagnosed, an AAA requires regular surveillance through imaging. Medical management includes addressing the risk factors, control of hypertension and hyperlipidemia, smoking cessation, and watchful waiting with surveillance. Elective surgery is recommended for aneurysms that continue to enlarge during surveillance or are larger than 5.5 cm. In the event of rupture, mortality is high in spite of emergency surgery. The USPSTF recommends one-time ultrasonographic screening for AAA in male ever smokers and aged 65–75. Ultrasonography is the preferred imaging modality for screening and surveillance.
Since the first implantation of an endograft in 1991, endovascular aneurysm repair (EVAR) rapidly gained recognition. Historical trials showed lower early mortality rates but these results were not maintained beyond 4 years. Despite newer-generation devices, higher rates of reintervention are associated with EVAR during follow-up. Therefore, the best therapeutic decision relies on many parameters that the physician has to take in consideration. Patient's preferences and characteristics are important, especially age and life expectancy besides health status. Aneurysmal anatomical conditions remain probably the most predictive factor that should be carefully evaluated to offer the best treatment. Unfavorable anatomy has been observed to be associated with more complications especially endoleak, leading to more re-interventions and higher risk of late mortality. Nevertheless, technological advances have made surgeons move forward beyond the set barriers. Thus, more endografts are implanted outside the instructions for use despite excellent results after open repair especially in low-risk patients. When debating about AAA repair, some other crucial points should be analysed. It has been shown that strict surveillance is mandatory after EVAR to offer durable results and prevent late rupture. Such program is associated with additional costs and with increased risk of radiation. Moreover, a risk of loss of renal function exists when repetitive imaging and secondary procedures are required. The aim of this article is to review the data associated with abdominal aortic aneurysm and its treatment in order to establish selection criteria to decide between open or endovascular repair.
Background
Evidence synthesis has seen major methodological advances in reducing uncertainty and estimating the sizes of the effects. Much less is known about how to assess the relative value of different outcomes.Objective
To identify studies that assessed preferences for outcomes in health conditions.Methods
Search strategy: we searched MEDLINE, EMBASE, PsycINFO and the Cochrane Library in February 2014. Inclusion criteria: eligible studies investigated preferences of patients, family members, the general population or healthcare professionals for health outcomes. The intention of this review was to include studies which focus on theoretical alternatives; studies which assessed preferences for distinct treatments were excluded. Data extraction: study characteristics as study objective, health condition, participants, elicitation method, and outcomes assessed in the study were extracted.Main resultsOne hundred and twenty-four studies were identified and categorized into four groups: (1) multi criteria decision analysis (MCDA) (n = 71), (2) rating or ranking (n = 25), (3) utility eliciting (n = 5) and (4) studies comparing different methods (n = 23). The number of outcomes assessed by method group varied. The comparison of different methods or subgroups within one study often resulted in different hierarchies of outcomes.ConclusionsA dominant method most suitable for application in evidence syntheses was not identified. As preferences of patients differ from those of other stakeholders (especially medical professionals), the choice of the group to be questioned is consequential. Further research needs to focus on validity and applicability of the identified methods.
Background:
Discrete choice experiments (DCEs) are increasingly used in health economics to address a wide range of health policy-related concerns.
Objective:
Broadly adopting the methodology of an earlier systematic review of health-related DCEs, which covered the period 2001-2008, we report whether earlier trends continued during 2009-2012.
Methods:
This paper systematically reviews health-related DCEs published between 2009 and 2012, using the same database as the earlier published review (PubMed) to obtain citations, and the same range of search terms.
Results:
A total of 179 health-related DCEs for 2009-2012 met the inclusion criteria for the review. We found a continuing trend towards conducting DCEs across a broader range of countries. However, the trend towards including fewer attributes was reversed, whilst the trend towards interview-based DCEs reversed because of increased computer administration. The trend towards using more flexible econometric models, including mixed logit and latent class, has also continued. Reporting of monetary values has fallen compared with earlier periods, but the proportion of studies estimating trade-offs between health outcomes and experience factors, or valuing outcomes in terms of utility scores, has increased, although use of odds ratios and probabilities has declined. The reassuring trend towards the use of more flexible and appropriate DCE designs and econometric methods has been reinforced by the increased use of qualitative methods to inform DCE processes and results. However, qualitative research methods are being used less often to inform attribute selection, which may make DCEs more susceptible to omitted variable bias if the decision framework is not known prior to the research project.
Conclusions:
The use of DCEs in healthcare continues to grow dramatically, as does the scope of applications across an expanding range of countries. There is increasing evidence that more sophisticated approaches to DCE design and analytical techniques are improving the quality of final outputs. That said, recent evidence that the use of qualitative methods to inform attribute selection has declined is of concern.
Discrete choice experiments (DCEs) are used to elicit preferences of current and future patients and healthcare professionals about how they value different aspects of healthcare. Risk is an integral part of most healthcare decisions. Despite the use of risk attributes in DCEs consistently being highlighted as an area for further research, current methods of incorporating risk attributes in DCEs have not been reviewed explicitly.
This study aimed to systematically identify published healthcare DCEs that incorporated a risk attribute, summarise and appraise methods used to present and analyse risk attributes, and recommend best practice regarding including, analysing and transparently reporting the methodology supporting risk attributes in future DCEs.
The Web of Science, MEDLINE, EMBASE, PsycINFO and Econlit databases were searched on 18 April 2013 for DCEs that included a risk attribute published since 1995, and on 23 April 2013 to identify studies assessing risk communication in the general (non-DCE) health literature.
Healthcare-related DCEs with a risk attribute mentioned or suggested in the title/abstract were obtained and retained in the final review if a risk attribute meeting our definition was included.
Extracted data were tabulated and critically appraised to summarise the quality of reporting, and the format, presentation and interpretation of the risk attribute were summarised.
This review identified 117 healthcare DCEs that incorporated at least one risk attribute. Whilst there was some evidence of good practice incorporated into the presentation of risk attributes, little evidence was found that developing methods and recommendations from other disciplines about effective methods and validation of risk communication were systematically applied to DCEs. In general, the reviewed DCE studies did not thoroughly report the methodology supporting the explanation of risk in training materials, the impact of framing risk, or exploring the validity of risk communication.
The primary limitation of this review was that the methods underlying presentation, format and analysis of risk attributes could only be appraised to the extent that they were reported.
Improvements in reporting and transparency of risk presentation from conception to the analysis of DCEs are needed. To define best practice, further research is needed to test how the process of communicating risk affects the way in which people value risk attributes in DCEs.
Relatively few outcomes have been examined in randomized comparisons of endovascular and open aortic aneurysm repair, and no patient input was obtained in the selection of these outcomes. The aim of this study was to identify patient-derived, potentially novel outcomes that may be used to guide future clinical trials in aneurysm surgery.
Focus group interviews were conducted with patients who had undergone endovascular or open aortic aneurysm repair. The discussions were transcribed and the transcript was analyzed by two indexers using constant-comparison analysis and grounded theory to identify potentially novel, patient-derived outcomes. Other potential themes relating to the patients' experience and their decision-making were also sought.
Six focus groups were conducted (three with endovascular aneurysm repair patients and three with open aortic aneurysm repair patients), with a median of six participants, 2 to 12 months from surgery. Functional outcomes were most commonly mentioned and emphasized by patients. Recovery time and energy level were most frequently verbalized as important in the decision-making process between endovascular and open aneurysm repair. Other potential outcomes identified as important to patients included postoperative pain, time to walking normally, loss of appetite, extent and location of incisions, impact on cognition, being able to go home after surgery, and impact on caregivers. In addition to these outcomes, we identified three themes relating to the patient's experience: undervaluing or underappreciating the risk of death during surgery, differing informational needs and level of involvement in decision-making, and unrealistic patient expectations about the risks of and recovery after the procedure.
Functional outcomes emerged as most important during qualitative analysis of patients' experiences with aneurysm repair. Perceived differences in recovery time were identified as an important consideration for aneurysm patients in deciding between open and endovascular repair. More work needs to be done clarifying the concept of recovery and other related functional outcomes for the development of methods to assess and to evaluate these in prospective clinical trials.
Abdominal aortic aneurysm (AAA) has a reported prevalence rate of 1.4% in the US. AAA rupture accounts for an estimated 15,000 deaths per year, rendering it the 10th leading cause of death in men over the age of 55. Endovascular repair (EVR) has proliferated in the last two decades as an increasingly popular alternative to traditional open surgery, and is now the default treatment in the majority of centres worldwide. This review article outlines the evidence supporting this stance. The development of EVR is reviewed, alongside trends in utilisation of this therapy over time. The evidence for the relative short-term and long-term outcomes of EVR and open AAA repair is discussed, and ongoing controversies surrounding the use of EVR are considered.
Objective: To estimate a value set for the calculation of Italian-specific quality-adjusted life years (QALYs), based on preferences elicited on EuroQol five-dimensional (EQ-5D) questionnaire health states using the time trade-off technique. Methods: The revised standard Measurement and Valuation of Health protocol was followed. Twenty-five health states, divided into three groups and given to 450 subjects, were selected to obtain 300 observations per state. Subjects aged 18 to 75 years were recruited to be representative of the Italian general adult population for age, sex, and geographical distribution. To improve efficiency, face-to-face interviews were conducted by using the Computer Assisted Personal Interviewing approach. Several random effects regression models were tested to predict the full set of EQ-5D questionnaire health states. Model selection was based on logical consistency of the estimates, sign and magnitude of the regression coefficients, goodness of fit, and parsimony. Results: The model that satisfied the criteria of logical consistency and was more efficient includes 10 main effect dummy variables for the EQ-5D questionnaire domain levels and the D1 interaction term, which accounts for the number of dimensions at levels 2 or 3 beyond the first. This model has an R 2 of 0.389 and a mean absolute error of 0.03, which are comparable to or better than those of models used in other countries. The utility estimates after state 11111 range from 0.92 (21111) to −0.38 (33333). Italian utility estimates are higher than those estimated in the United Kingdom and Spain and used so far to assess QALYs and conduct cost-utility evaluations in Italy. Conclusions: A specific value set is now available to calculate QALYs for the conduction of health economic studies targeted at the Italian health care system.
To determine whether men with small abdominal aortic aneurysm have a preference between either endovascular or open aneurysm repair for future treatment.
Prospective study of self-declared treatment preference following receipt of a validated patient information pack.
Men aged 65-84 years (n=237) with asymptomatic aneurysm (4.0-5.4 cm) detected by population-based screening.
An unbiased, validated patient information pack and questionnaire were developed to conduct a postal survey.
One hundred sixty seven participants (70%) returned a completed questionnaire; 24 (10%) did not respond at all. Initially, only 38 (23%) declared a treatment preference. After reading the information pack, 130 participants (80%) declared a treatment preference: 30 preferred open repair (18%), 77 endovascular repair (46%), 23 were happy with either option (14%) and only 34 remained without any preference (20%). Nearly all (92%) thought that the information pack had prepared them well for future discussions with clinicians and with no single feature identified as influencing the preference-making process, 66 respondents (40%) still opted to 'take the advice of the doctor'.
The patient information pack facilitated the development of treatment preferences with endovascular repair being preferred to open repair. Nevertheless for patient-centred care, vascular centres must continue to safely provide both open and endovascular repair.
Qualitative research methods have a long history in the social sciences and deserve to be an essential component in health and health services research. Qualitative and quantitative approaches to research tend to be portrayed as antithetical; the aim of this series of papers is to show the value of a range of qualitative techniques and how they can complement quantitative research.
Background:
Few data are available on the long-term outcome of endovascular repair of abdominal aortic aneurysm as compared with open repair.
Methods:
From 1999 through 2004 at 37 hospitals in the United Kingdom, we randomly assigned 1252 patients with large abdominal aortic aneurysms (> or = 5.5 cm in diameter) to undergo either endovascular or open repair; 626 patients were assigned to each group. Patients were followed for rates of death, graft-related complications, reinterventions, and resource use until the end of 2009. Logistic regression and Cox regression were used to compare outcomes in the two groups.
Results:
The 30-day operative mortality was 1.8% in the endovascular-repair group and 4.3% in the open-repair group (adjusted odds ratio for endovascular repair as compared with open repair, 0.39; 95% confidence interval [CI], 0.18 to 0.87; P=0.02). The endovascular-repair group had an early benefit with respect to aneurysm-related mortality, but the benefit was lost by the end of the study, at least partially because of fatal endograft ruptures (adjusted hazard ratio, 0.92; 95% CI, 0.57 to 1.49; P=0.73). By the end of follow-up, there was no significant difference between the two groups in the rate of death from any cause (adjusted hazard ratio, 1.03; 95% CI, 0.86 to 1.23; P=0.72). The rates of graft-related complications and reinterventions were higher with endovascular repair, and new complications occurred up to 8 years after randomization, contributing to higher overall costs.
Conclusions:
In this large, randomized trial, endovascular repair of abdominal aortic aneurysm was associated with a significantly lower operative mortality than open surgical repair. However, no differences were seen in total mortality or aneurysm-related mortality in the long term. Endovascular repair was associated with increased rates of graft-related complications and reinterventions and was more costly. (Current Controlled Trials number, ISRCTN55703451.)
Objective
Factors influencing the choice between endovascular (endovascular aneurysm repair, EVAR) and open repair (OPEN) of abdominal aortic aneurysm (AAA) are of increasing interest. We quantified their importance among the different subjects involved in the treatment.Methods
Pre- and postoperative patients (pts), their relatives and vascular surgeons completed questionnaires evaluating six treatment characteristics: anaesthesia; recovery time to basic everyday activities; risk of re-intervention at 5 years (RR); complexity of follow-up; risk of major complications; and additional cost of intervention (AC). Through a discrete choice experiment, hypothetical scenarios of treatment were obtained and the relative importance (RI) of each characteristic was determined through a conditional logistic regression model.ResultsA total of 160 pts, 102 relatives and 30 surgeons from nine centres completed the questionnaires. Major complications and re-intervention risk were the most important characteristics (RI = 56.0% and 27.2%, respectively) for all the respondent categories. Pts and their relatives considered very important also a possible out-of-pocket AC. Recovery time and type of anaesthesia were among the least important characteristics, including hospital additional cost for surgeons. The different categories of respondents showed different opinions towards different treatment characteristics depending also on possible previous treatment.Conclusion
Preferences for AAA treatment characteristics differ between groups of involved subjects. Understanding individuals’ preferences could help in optimising treatment benefits.
Established in 1987, the EuroQol Group initially comprised a network of international, multilingual and multi-disciplinary researchers from seven centres in Finland, the Netherlands, Norway, Sweden and the UK. Nowadays, the Group comprises researchers from Canada, Denmark, Germany, Greece, Japan, New Zealand, Slovenia, Spain, the USA and Zimbabwe. The process of shared development and local experimentation resulted in EQ-5D, a generic measure of health status that provides a simple descriptive profile and a single index value that can be used in the clinical and economic evaluation of health care and in population health surveys. Currently, EQ-5D is being widely used in different countries by clinical researchers in a variety of clinical areas. EQ-5D is also being used by eight out of the first 10 of the top 50 pharmaceutical companies listed in the annual report of Pharma Business (November/December 1999). Furthermore, EQ-5D is one of the handful of measures recommended for use in cost-effectiveness analyses by the Washington Panel on Cost Effectiveness in Health and Medicine. EQ-5D has now been translated into most major languages with the EuroQol Group closely monitoring the process.
The purpose of this study is to describe and interpret what it means for patients to be diagnosed with an abdominal aortic aneurysm (AAA) and how they experience treatment. AAA is usually asymptomatic and often discovered coincidentally in conjunction with a diagnostic workup for other medical problems. Twenty patients who had undergone 2 different surgical procedures were sequentially invited for interviews 1 month following surgery. A hermeneutic approach was used. For all patients three themes emerged: an inability to come to terms with a life-threatening condition, a sense of living on borrowed time, and a sense of being granted a new lease on life. The theme that emerged for patients with open repair was that diagnosis with AAA was an ordeal to endure, while the theme for patients who underwent endovascular treatment was a sense of gratitude, security, and insecurity. Once the aneurysm was discovered patients were convinced that they were both blessed and saved, along with a sense of gratitude. Pre- and postoperative nursing care strategies can be developed based on the findings from this study.
There is no evidence about patient preferences for treatment of abdominal aortic aneurysms (AAA) by endovascular aneurysm repair (EVAR) or open surgical repair (OSR). This study examined patient preferences for elective future aneurysm repair and factors that may influence such preferences.
Patients with small AAAs under ultrasound scan surveillance at two United Kingdom (UK) hospitals participated in a semi-structured telephone interview. Features of the two techniques were assessed with regard to their influence on the preferences of participants for EVAR or OSR, using a Likert scale. In addition, participants ranked the relative importance of 14 features against each other.
Fifty-six out of 100 eligible participants (56%) completed the semi-structured telephone interview. Of those, 84% (47 patients) said they would prefer a future EVAR repair. Patients who expressed a preference for OSR were significantly younger. Risks of major organ failure and death were most commonly judged as important features in influencing patient preference (Likert scale score 5/5). Risk of death was also most frequently ranked above all other features. Postoperative morbidity and mortality were regarded by patients as more important than the need for surveillance and risk of long-term problems with EVAR. Type of incision and radiation exposure were both given low Likert scale scores of 1/5, and the risk of sexual dysfunction was most frequently ranked as the least important feature of either operation, out of 14 other features.
When presented with detailed information about EVAR and OSR, most patients with small aneurysms would prefer EVAR.
This study was performed to assess patient preferences for consequences of 3 coronary revascularization procedures: angioplasty, conventional coronary bypass surgery, and minimally invasive coronary bypass surgery.
A nationwide sample of 3 types of respondents was recruited: respondents with no heart disease (n = 89), respondents with heart disease who had not undergone cardiac surgery (n = 97), and respondents with heart disease who had undergone cardiac surgery (n = 118).
Sixty-two percent ranked the risk of repeat revascularization as the most important concern, followed by postprocedure pain (22%), time to recovery of physical functioning (8%), time in hospital (4%), and body appearance (4%). Respondents preferred angioplasty to conventional and minimally invasive cardiac surgery if the 3-year risk of repeat revascularization with angioplasty were to decline to less than 28% and 21%, respectively.
These data suggest that patient preference should influence individual and policy recommendations when choosing among coronary revascularization procedures.
The long-term effects of endovascular aortic aneurysm repair on cognitive function and quality of life are not known.
The cognitive function and quality of life of 82 patients undergoing aortic aneurysm repair (34 endovascular and 48 conventional procedures) were assessed before and 6 months after operation. Cognitive function was quantified using a battery of psychometric tests. Quality of life was assessed with the Medical Outcomes Short Form 36 (SF-36) questionnaire.
Data at 6 months were available for 78 per cent of patients. As a group the patients showed a significant decline on one cognitive function test (visual search) and on two domains of the SF-36 (physical function and vitality) when they were reassessed. There were no significant differences between patients undergoing endovascular or conventional aneurysm repair after 6 months in cognitive function or quality of life.
Endovascular aneurysm surgery had a similar impact on health-related quality of life and cognitive function compared with conventional aneurysm repair. Patients in both groups demonstrated a significant decline in cognitive function.
To assess how patients perceive health-related quality of life (HRQOL) after endovascular and open abdominal aortic aneurysm (AAA) repair.
Forty-two consecutive patients (33 men; mean age 74 years, range 46-81) were assessed prospectively before and after elective endovascular (n = 21) and open (n = 21) AAA repair. Aneurysm morphology dictated the type of repair. The two patient groups were similar regarding age, gender, comorbidities, and cardiopulmonary function. Data concerning surgical trauma were compiled. The Nottingham Health Profile (NHP) score was used to assess the perceived HRQOL (criteria: pain, mobility, sleep, emotion, energy, and isolation) preoperatively and at 5, 30, and 90 days postoperatively. Specific treatment perception questions were added.
One patient from each group died, leaving 40 patients to complete the study. Two patients with open repair and 1 patient with endovascular repair were unfit to answer the questionnaire on day 5. The HRQOL improved at 3 months compared with the preoperative values (p < 0.05). No significant difference was found at any time between the open and endovascular groups regarding the NHP score, although the operative time, blood loss, analgesic use, and hospital stay were significantly in favor of endovascular repair. Reinterventions were required in 5 patients with endovascular and 2 patients with open repair.
In general, 3 months after AAA repair, the perceived HRQOL seems better than before treatment. Perceived HRQOL is similar after endovascular and open AAA repair despite greater surgical trauma in open surgery. This may reflect the higher number of reinterventions following endovascular repair but also difficulties in defining HRQOL.
Detailed information on functional outcome after open abdominal aortic aneurysm (AAA) repair is sparse. Information about functional outcome of open AAA repair is essential to allow comparison of treatment modalities.
To determine the functional outcome of patients after open repair of AAA, we reviewed 154 consecutive, nonemergency open repairs of infrarenal AAAs between 1990 and 1997 and each patient's medical records. Clinical variables were recorded for each patient, as were multiple outcomes, including ambulatory status, independent living status, current medical condition, and the patient's perception of recovery and satisfaction. Eighty-seven patients or their families were available for current telephone interview to obtain information about objective functional activities, including walking and driving, and subjective functional information, including assessment of complete recovery and willingness to undergo AAA repair again. Chart data were available for all 154 patients.
There were 42 women and 112 men. A total of 139 operations were elective, and 15 were urgent. The operative mortality rate was 4%, mean hospital stay was 10.7 +/- 1.3 days, and mean intensive care unit stay was 4.57 +/- 1.17 days. Seventeen (11%) patients required transfer to a skilled nursing facility with a mean stay of 3.66 +/- 2.9 months. All patients were ambulatory preoperatively, whereas at last follow-up (median, 25 months; range, 0.13-108.5 months), 100 (64%) of the patients remained ambulatory, 34 (22%) required assistance, and 12 (14%) were nonambulatory. At current assessment by telephone interview, 33% of patients described a decrease in their functional activity including driving, shopping, and traveling compared with their preoperative status, whereas 67% were unchanged. When asked to assess their own degree of recovery, 64% of patients stated that they experienced complete recovery with an average time to recovery of 3.9 months, whereas 33% said they had not fully recovered at a mean follow-up of 34 months. Sixteen (18%) patients said they would not undergo AAA repair again knowing the recovery process, even though they appeared to fully understand the implication of AAA rupture.
Patients undergoing open AAA repair generally experienced significant freedom from surgical complications. However, substantial functional impairment was present. It is unclear whether the functional disability resulted from the AAA surgery or from aging and comorbidities unrelated to surgery.
NICE should consider using them for patient centred evaluations of technologies
In many publicly provided healthcare systems, limited resources coupled with unlimited demand result in decisions having to be made about the efficient allocation of scarce resources. This raises questions of how services should be provided (for example, how should patients with cancer be treated? should central clinics, which reduce waiting time but increase travel time for patients, be introduced?) through to the optimal provision and the financing of health care (for example, how should we pay doctors to encourage them to work in remote and rural areas? what would encourage nurses to return to the labour market?). Given the lack of a market for health care, economics techniques inform such decisions.1 One approach adopted by and further developed in health economics over the past decade is discrete choice experiments.2 3 In this issue Sculpher et al use this approach to consider patients' preferences in the treatment of prostate cancer (p 382).4 …
Whether or not to undergo surgery for abdominal aortic aneurysm (AAA), and whether to have open or endovascular repair (EVAR), is a complex decision that relies heavily on patient preferences, and yet little is known about the patient perspective on informed consent in this context. This study explores patients' views on their decision-making processes and the quality of surgeon-patient communication during informed consent for AAA repair.
We conducted in-depth interviews with AAA patients (n = 20) who underwent open AAA repair, endovascular repair, or declined surgery. Data were independently transcribed and analyzed by a team of individuals with diverse backgrounds, using the constant comparative method of analysis and systematic coding procedures.
Patients who had seen surgeons from academic, private practice, and VA settings were interviewed.
Patients' opinions regarding the nature, scope, and content of informed consent for AAA repair.
We identified four central themes characterizing patients' experiences with informed consent for AAA repair: 1) patients did not appreciate the scope of their options; 2) patients demonstrated that they were not adequately informed prior to making a decision; 3) patients differed in the scope and content of information they desired during informed consent; and 4) trust in the surgeon had an impact on the informed consent process.
Our research highlights the limitations of the informed consent encounter in the current clinical context, and points to several ways in which informed consent could be improved. Adapting the informed consent encounter to incorporate the patient's perspective is critical in order to ensure that the decision regarding AAA repair is consistent with the patient's informed preference.
WMA) Declaration of Helsinki Adopted by the 18th World medical Assembly
10 World Medical Association (WMA) Declaration of Helsinki.
Adopted by the 18th World medical Assembly, Helsinki,
Finland, June 1964, amended by the 29th World Medical
Assembly, Tokyo, Japan, October 1975, the 35th World
Medical Assembly, Venice, Italy, October 1983, and the
41st World Medical Assembly, Hong Kong, September
1989.
13 The United Kingdom EVAR Trial Investigators. Endovascular versus open repair of abdominal aortic aneurysm
13 The United Kingdom EVAR Trial Investigators. Endovascular
versus open repair of abdominal aortic aneurysm. N Engl J Med
2010;362:1863e71.