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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
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.
... Recent studies have shown that patients, physicians, budget holders, and other individuals involved do not necessarily agree on the importance of some aspects of possible treatment options. 21,22,[24][25][26][27][28][29] Reaching an optimal decision requires being informed and aware of the opinions and preferences of all interested parties. Understanding the similarities and discrepancies in treatment preferences of the different individuals involved can be useful for improving the communication between them to uncover alternative approaches to treatment strategy, with positive effects on patient satisfaction, compliance, and, consequently, the effectiveness and efficiency of the treatments. ...
... The present DCE study, designed according to current guidelines 32 and experience gained from previous research in the Italian health care system, 25,26,33,34 was conducted in four main phases: 1) design of the DCE, consisting of choosing characteristics, assigning levels to each characteristic, and constructing the scenarios to be evaluated; 2) development of the survey instrument; 3) data collection; and 4) data analysis and interpretation of results. Details of the design process are reported in the Supplementary material. ...
Objective
To estimate preferences in relevant treatment characteristics evaluated by different groups involved in the management of patients with rheumatic diseases.
Subjects and methods
We surveyed patients with rheumatic diseases, and rheumatologists, nurses, and pharmacists with experience in treatment with/provision of biologic drugs for these patients. Through a discrete choice experiment, participants evaluated 16 possible scenarios in which pairs of similarly efficacious treatments were described with six characteristics: 1) frequency of administration; 2) mode and place of administration; 3) manner, helpfulness, efficiency, and courtesy of health personnel; 4) frequency of reactions at the site of drug administration; 5) severity of generalized undesired/allergic reactions; and 6) additional cost. The direction and strength of preferences toward each characteristic level and the relative importance of each characteristic were estimated through a random-effects conditional logistic regression model.
Results
In total, 513 patients, 110 rheumatologists, 51 nurses, and 46 pharmacists from 30 centers in Italy participated. Characteristics 3, 4, and 6 were the most important for every subgroup; 1 was least important for patients and rheumatologists, 2 was least important for pharmacists, and 2 and 5 were least important for nurses. For characteristic 2, pharmacists preferred subcutaneous self-injection with a syringe; nurses preferred assisted infusion at an infusion center close to the patient’s home; patients and rheumatologists preferred subcutaneous self-injection with a pen.
Conclusion
The different preferences for some characteristics shown by the different groups can play an important role, together with purely clinical aspects, in the choice and consequent benefit of treatments, contributing also to a more satisfactory use of resources.
... 43 46 55 One study specified they had framed their cost attribute in a different way for patients (out-ofpocket payment) and physicians (as additional hospital cost). 63 The majority of studies (n=34) reported accounting for heterogeneity within samples; this was most commonly analysed using subgroups 32 33 37 38 44 47 50-53 56 58 60 62 63 66 67 or incorporating respondent information as covariates in the model. 9 31 43 59 64 In other studies, heterogeneity was accounted for by allowing random parameters in the model to be estimated 34 40 or using a heteroskedastic condition logit model. ...
... Similarly, patients cared more about delivery and timing (eg, 'route of drug administration') 61 than healthcare providers. There was evidence of some discordance around issues of patient and healthcare provider relationship (eg, 'physician's attitude to patients'), 32 morbidity (eg, 'time necessary to recover (defined as returning to normal activities)') 63 and access (eg, extra cost to patient) 67 with patients rating this as more important than healthcare providers. Figure 2 Synthesis of concordance between patient and physician preferences for different types of attributes. ...
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.
... Although early applications were used to quantify process utility [9,10], more recent applications have focused on patient prefer- ences 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 clini- cians [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 prefer- ences 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 clini- cians [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.
... 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. 359,360 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. ...
... Parents can be included to represent their children and family members to represent older relatives [3,4,30,49,70,93,98]. However, their preferences might differ from those of the patients because they might not assign the same values to various risks and benefits [4,99]. ...
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.
... 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.
... The economical aspect should also be considered because of the higher costs associated with EVAR. Another hindrance could be the pre-acquired concepts on modern surgical techniques that patients bring from the electronic media, which generates a layperson preference [1,40,41] , and also the manner both techniques are offered to patients by the attending physician [42] . ...
Introduction:
Endovascular repair (EVAR) of abdominal aortic aneurysm has become the standard of care due to a lower 30-day mortality, a lower morbidity, shorter hospital stay and a quicker recovery. The role of open repair (OR) and to whom this type of operation should be offered is subject to discussion.
Objective:
To present a single center experience on the repair of abdominal aortic aneurysm, comparing the results of open and endovascular repairs.
Methods:
Retrospective cross-sectional observational study including 286 patients submitted to OR and 91 patients submitted to EVAR. The mean follow-up for the OR group was 66 months and for the EVAR group was 39 months.
Results:
The overall mortality was 11.89% for OR and 7.69% for EVAR (P=0.263), EVAR presented a death relative risk of 0.647. It was also found a lower intraoperative bleeding for EVAR (OR=1417.48±1180.42 mL versusEVAR=597.80±488.81 mL, P<0.0002) and a shorter operative time for endovascular repair (OR=4.40±1.08 hoursversus EVAR=3.58±1.26 hours,P<0.003). The postoperative complications presented no statistical difference between groups (OR=29.03% versusEVAR=25.27%, P=0.35).
Conclusion:
EVAR presents a better short term outcome than OR in all classes of physiologic risk. In order to train future vascular surgeons on OR, only young and healthy patients, who carry a very low risk of adverse events, should be selected, aiming at the long term durability of the procedure.
... 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 Italy234. 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 sectors56789101112. The EQ-5D questionnaire is a quickly administered instrument that makes it possible to obtain a meaningful description and measurement of health. ...
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.
... 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 Italy234. 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 sectors56789101112. The EQ-5D questionnaire is a quickly administered instrument that makes it possible to obtain a meaningful description and measurement of health. ...
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.
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.
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.
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.
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.
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.
Duplex ultrasound has become the reference standard in assessing the morphology and haemodynamics of the lower limb veins. The project described in this article was an initiative of the Union Internationale de Phlébologie (UIP). The aim was to obtain a consensus of international experts on the methodology and terminology to be used for assessment after treatment of incompetent superficial and perforating veins in the lower limb by ultrasound imaging.
The study design was consensus meetings leading to a consensus document.
The UIP invited group submitted relevant literature references and written contributions concerning the methodology, terminology and value of duplex imaging after treatment. The authors prepared a draft document that was circulated to a larger group of experts and revised according to the comments received. Eventually, all participants agreed upon the final version of the article.
Formal analysis of the results of interventions for varicose veins relies on adequate preoperative assessment and a careful description of the procedure employed. The timing of investigations of outcome should be classified as immediate (1-4 weeks), short-term (1 year), midterm (2-3 years) and long-term (5 years or more). The examination should employ standard methodology and formally described variables, which can be tailored to the intervention that was undertaken. The experts have made detailed recommendations concerning the methods to be used for duplex ultrasound examination and reporting after various treatments for varicose veins, including novel treatments under scientific study.
Duplex ultrasonography is a fundamental component of the investigation of the lower limb venous system after treatment for varicose veins.
Guidelines and protocols assist in the clinical management of patients, helping to utilise available resources efficiently, however, there is limited documented guidance on surveillance of patients following open arterial surgery. The frequency of clinical follow up, Doppler ultrasound measurements and radiological imaging should all be justified. Here we review the available literature to offer an evidenced based approach to postoperative care.
An electronic search was made of Medline and Embase databases through September 2009 revealing over 2300 studies in the initial searches. Following title and abstract screening, the relevant medical literature concerning post-operative surveillance of open vascular procedures was reviewed (300 papers). 42 papers were included in this review. Surveillance recommendations were constructed from the evidence presented.
Detailed anatomical imaging is available for the technical assessment in the majority of patients' postoperative management; however there is little Level 1 evidence to guide modality or timing. Grades B and C recommendations form the majority of surveillance recommendations. Clinical review remains the mainstay of surveillance following open peripheral arterial surgery. Duplex scanning is the imaging modality of choice when indicated in most instances. Minimal data exists to quantify quality of life or intervention efficacy.
The study aimed to review the results of endovascular aneurysm repair (EVAR) using a novel sac-anchoring endoprosthesis in patients with favourable and adverse anatomy.
This is a prospective, multicentre, clinical trial.
The Nellix endoprosthesis consists of dual, balloon-expandable endoframes, surrounded by polymer-filled endobags, which obliterate the aneurysm sac and maintain endograft position.
The study reviewed worldwide clinical experience and Core Lab evaluation of computed tomography (CT) scans.
From 2008 to 2010, 34 patients (age 71 ± 8 years, abdominal aortic aneurysm (AAA) diameter 5.8 ± 0.8 cm) were treated at four clinical sites. Seventeen patients (50%) met the inclusion criteria for Food and Drug Administration (FDA)-approved endografts (favourable anatomy); 17 (50%) had one or more adverse anatomic feature: neck length <10 mm (24%), neck angle >60° (9%) and iliac diameter >23 mm (38%). Device deployment was successful in all patients; iliac aneurysm treatment preserved hypogastric patency. Perioperative mortality was 1/34 (2.9%); one patient died at 10 months of congestive heart failure (CHF); one patient had a secondary procedure at 15 months. During 15 ± 6 months follow-up, there were no differences in outcome between favourable and adverse anatomy patients. Follow-up CT extending up to 2 years revealed no change in aneurysm size or endograft position and no new endoleaks.
Favourable and adverse anatomy patients can be successfully treated using the Nellix sac-anchoring endoprosthesis. Early results are promising but longer-term studies are needed.
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.
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.
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.