Objectives: To calculate the costs of blood collection, testing, storage, and transfusion in Greece.

Methods: Costing information was collected from two large public hospitals, in Athens and Crete, that also act as blood banks. Given that private health care accounts for 40 percent of total health spending, the same costs were also considered in a private setting by collecting key reagent cost data from a leading private hospital in Athens. Mainly direct costs were considered (advertising campaigns, personnel, storage and maintenance, reagent costs, transportation costs from blood bank to end-use hospitals, and cross-matching and transfusion costs in receiving hospitals) and some indirect costs (opportunity cost of blood donorship).

Results: Captive donorship accounts for over 50 percent of the national blood supply. A unit of blood transfused would cost between €294.83 and €339.83 in public hospitals and could reach €413.93 in a private facility. This figure may be an underestimate, as it excludes opportunity costs of blood transfusion for patients and the healthcare system.

Conclusions: Blood has a significant cost to the health system. Policy makers and practitioners should encourage its rational use, build on current policies to further improve collection and distribution, encourage further volunteer donorship in Greece, and also consider alternatives to blood where the possibility exists.

Objectives: The objective of this study was to collect all systematic reviews on invasive strategies for acute coronary syndromes (ACS) and reanalyze the data in these reviews to reach combined estimates, as well as to make predictions on the effectiveness and risk of harm so as to facilitate relevant decision making in health care.

Methods: The data sources used were the following electronic databases, searched from 1994 to September 2004: Cochrane Database of Systematic Reviews; Cochrane Central Register of Controlled Trials; DARE, HTA, EED (NHS CRD); MEDLINE(R) In-Process, Other Non-Indexed Citations, MEDLINE(R), and PubMed (2000 to 2004). References to the identified systematic reviews were checked. An ancillary search to identify recent randomized controlled trials (RCTs) covering the period from January 2003 to January 2006 was done in MEDLINE(R). We included systematic reviews of RCTs on patients with ACS. In unstable angina and non–ST-elevation myocardial infarction (UA/NSTEMI), eligible reviews had to compare early routine invasive strategy with early selective invasive strategy. In ST-elevation myocardial infarction (STEMI), a comparison between primary percutaneous coronary intervention (PCI) and thrombolytic therapy was required. The methodological quality of the reviews was assessed, and a standardized data extraction form was used. Results for the main outcomes of the RCTs in the reviews were reanalyzed. An additional search of those RCTs not included in the meta-analyses was performed for UA/NSTEMI and short-term morality data on STEMI. Bayesian models were constructed to estimate the uncertainty about a possible treatment effect and to make predictions and probability statements. Main results are based on these analyses. Mortality was considered as the primary outcome measure.

Results: One systematic review on invasive strategies was identified for UA/NSTEMI and nine on invasive strategies for STEMI. Five reviews of the latter that were published after the year 2000 were included for the final analysis. The median quality score was 10.5 (range, 7–13; n = 6) on a scale from 0 to 18 points. An updated literature search identified one further RCT on UA/NSTEMI. Regarding NSTEMI and mortality, the average risk difference favoring an early invasive treatment strategy compared with early conservative strategy was .6 percent (95 percent credible interval [CrI], −2.1 to 1.0). Predicted risk (relative risk/risk difference scales) of doing harm was 26.7/26.6 percent. Regarding STEMI and mortality, the absolute risk reduction in favor of primary PCI over thrombolysis was 4.1 percent (95 percent CrI, −7.1 to −1.1) when PCI was compared with streptokinase and 1.2 percent (95 percent CrI, −2.7 to .2) when compared with fibrin-specific thrombolytics. Predicted risk of harm was 8.9/5.3 percent and 8.0/13.3 percent, respectively.

Conclusions: There seems to be at present no solid evidence for survival benefit on early invasive strategy for UA/NSTEMI as a broad diagnostic group, and the risk of doing harm should be considered. Also, the evidence for PCI to decrease early mortality after STEMI is scanty. Estimations of predicted harm may further aid decisions on whether to implement the new treatment over the old one. It may also give an additional dimension for interpreting the results of any meta-analysis.

Objectives: The aim of the study was to evaluate the validity of the systematic reviews as a source of best evidence and to present and interpret the evidence of the systematic reviews on effectiveness of surgery and percutaneous interventions for stable coronary artery disease.

Methods: Electronic databases were searched without language restriction from January 1966 to March 2004. The databases used included the Cochrane Database of Systematic Reviews, the Cochrane Central Register of Controlled Trials, DARE, the Health Technology Assessment Database, MEDLINE(R), MEDLINE(R) In-Process & Other Non-Indexed Citations. We included systematic reviews of randomized clinical trials on patients with stable coronary heart disease undergoing percutaneous coronary intervention or coronary artery bypass surgery in comparison with medical treatment or a comparison between invasive techniques. At least one of the following outcomes had to be reported: death, myocardial infarction, angina pectoris, revascularization. The methodological quality was assessed using a modified version of the scale devised by Oxman and Guyatt (1991). A standardized data-extraction form was used. The method used to evaluate clinical relevance was carried out with updated method guidelines from the Cochrane Back Research Group. Quantitative synthesis of the effectiveness data is presented.

Results: We found nineteen systematic reviews. The median score of validity was 13 points (range, 6–17 points), with a maximum of 18 points. vCoronary artery bypass surgery gives better relief of angina, and the need for repeated procedures is reduced after bypass surgery compared with percutaneous interventions. There is inconsistent evidence as to whether bypass surgery improves survival compared with percutaneous intervention. A smaller need for repeated procedures exists after bare metal stent and even more so after drug-eluting stent placement than after percutaneous intervention without stent placement. However, according to the current evidence, these treatment alternatives do not differ in terms of mortality or myocardial infarction.

Conclusions: We found some high-quality systematic reviews. There was evidence on the potential of invasive treatments to provide symptomatic relief. Surgery seems to provide a longer-lasting effect than percutaneous interventions with bare metal stents or without stents. Evidence in favor of drug-eluting stents so far is based on short-term follow-up and mostly on patients with single-vessel disease.

Objectives: The aim of this study was to assess the cost-effectiveness of a class-based exercise program supplementing a home-based program when compared with a home-based program alone. In addition, we estimated the probability that the supplementary class program is cost-effective over a range of values of a decision maker's willingness to pay for an additional quality-adjusted life-year (QALY).

Methods: The resource use and effectiveness data were collected as part of the clinical trial detailed elsewhere. Unit costs were estimated from published sources. The net benefit approach to cost-effectiveness analysis is used to estimate the probability of the intervention being cost-effective.

Results: The addition of a supplementary class-based group results in an increase in QALYs and lower costs. For all plausible values of a decision maker's willingness to pay for a QALY, the supplementary class group is likely to be cost-effective.

Conclusions: The addition of a class-based exercise program is likely to be cost-effective and, on current evidence, should be implemented.

Objectives: The aim of this study was to assess the cost-effectiveness of drotrecogin alfa (activated) compared with best supportive care in a UK cohort of adult intensive-care patients with severe sepsis.

Methods: A systematic review of evidence on the clinical- and cost-effectiveness of drotrecogin alfa (activated) was undertaken, and a decision-analytic model was developed to estimate the cost-effectiveness of treatment in the United Kingdom. Trial data from the Recombinant Human Activated Protein C Worldwide Evaluation in Severe Sepsis (PROWESS) study have been synthesized with other data, including UK data on severe sepsis, to estimate the costs and consequences of treatment over time.

Results: For patients with severe sepsis and multiple organ dysfunction, the estimates of cost per life year and cost per quality-adjusted life year (QALY) are £4,931 and £8,228, respectively. For patients with severe sepsis alone, the cost per life-year and cost per QALY are £5,495 and £9,161, respectively.

Conclusions: Whereas the therapeutic cost for drotrecogin alfa (activated) appears high (at around £5,000 per patient) and the potential impact on the provider budget is considerable, drotrecogin alfa (activated) is clinically effective, represents a cost-effective use of resources, and is a significant advance in the treatment of severe sepsis in patients requiring intensive care.

Objectives: The aim of this study was to obtain information from members of the International Network of Agencies for Health Technology Assessment (INAHTA) on their involvement of consumers (patients, carers, and related organizations) in their programs.

Methods: A questionnaire for a survey was developed and sent to member agencies in October 2005.

Results: Of the thirty-seven agencies that provided responses, 57 percent involve consumers in some aspects of their HTA programs and 83 percent intend to involve consumers in the future. Summaries of HTA reports that are intended to be easily understood by consumers are prepared by 49 percent of the agencies, and 36 percent involve consumers in dissemination of HTA material.

Conclusions: Most INAHTA members involve consumers in some aspects of their programs, although not always routinely. Involvement seems likely to increase in the future.

Objectives: The objectives of this study were to identify, in a systematic literature review, published studies having used quality-adjusted life years (QALYs) based on actual measurements of patients' health-related quality of life (HRQoL) and to determine which HRQoL instruments have been used to calculate QALYs. Furthermore, the aims were to characterize studies with regard to medical specialty, intervention studied, results obtained, quality, country of origin, QALY gain observed, and interpretation of results regarding cost-effectiveness.

Methods: Systematic searches of the literature were made using the MEDLINE, Embase, CINAHL, SCI, and Cochrane Library electronic databases. Initial screening of identified articles was based on abstracts read independently by two of the authors; full-text articles were again evaluated by two authors, who made the final decision on which articles should be included.

Results: The search identified 3,882 articles; 624 were obtained for closer review. Of the reviewed full-text articles, seventy reported QALYs based on actual before–after measurements using a valid HRQoL instrument. The most frequently used instrument was EuroQol HRQoL instrument (EQ-5D, 47.5 percent). Other instruments used were Health Utilities Index (HUI, 8.8 percent), the Rosser–Kind Index (6.3 percent), Quality of Well-Being (QWB, 6.3 percent), Short Form-6D (SF-6D, 5.0 percent), and 15D (2.5 percent). The rest (23.8 percent) used a direct valuation method: Time Trade-Off (10.0 percent), Standard Gamble (5.0 percent), visual analogue scale (5.0 percent), or rating scale (3.8 percent). The most frequently studied medical specialties were orthopedics (15.5 percent), pulmonary diseases (12.7 percent), and cardiology (9.9 percent). Ninety percent of the studies came from four countries: United Kingdom, United States, Canada, the Netherlands. Approximately half of the papers were methodologically high quality randomized trials. Forty-nine percent of the studied interventions were viewed by the authors of the original studies as being cost-effective; only 13 percent of interventions were deemed not to be cost-effective.

Conclusions: Although QALYs gained are considered an important measure of effectiveness of health care, the number of studies in which QALYs are based on actual measurements of patients' HRQoL is still fairly limited.

Objectives: Recent policy recommendations for cervical screening include liquid-based cytology. This new approach could improve laboratory throughput, reducing the waiting time for test results. New guidelines also standardize the interval for screening, with women aged 25–50 offered screening every 3 years and women aged 50–64 every 5 years. Quantitative evidence on the preferences of women for alternative screening programs is limited; this study, therefore, elicits such preferences.

Methods: A postal questionnaire using a discrete choice experiment was mailed to 2,000 women in the Tayside Health Board region of Scotland.

Results: A response rate of 44 percent from those women who had previously had a smear was achieved. Women had a significant positive preference for reductions in recall rates and waiting time for results. Women preferred more frequent screening, particularly those aged 50+. Expected reductions in the chance of recall from the conventional Pap smear to the new liquid-based cytology were associated with a willingness to pay of £41. Women aged 50+ would be willing to pay £42 to increase the frequency of screening from every 5 to every 3 years. Service characteristics did not influence screening participation.

Conclusions: Guidance to move to liquid-based cytology will meet women's preferences for fewer repeat cervical smears and should reduce waiting time for results. However, proposals to increase screening intervals for those aged 50+ are inconsistent with the preferences for this age group. From a policy perspective, our study results suggest that the changes in attributes of the service such as unsatisfactory smear rates and frequency of screening, will improve service efficiency without affecting participation rates.

Objectives: Assessment of willingness to pay (WTP) by contingent valuation (CV) and choice experiments (CE) is increasingly performed in economic evaluation of health care. However, the question of whether the methods for measuring WTP are acceptable to decision makers and scientists has remained largely unacknowledged. The aim of this study was to learn more about decision makers' and scientists' opinion concerning these methods.

Methods: An expert group developed a questionnaire consisting of key items that may influence the opinion about CV and CE according to the constructs “attitude toward behavior,” “subjective norm,” and “behavioral intention” as defined by the Theory of Reasoned Action by Ajzen and Fishbein. In a survey, seventy-seven decision makers representing key institutions in the German healthcare system and forty-two scientists in health economics completed the questionnaire.

Results: Scientists and decision makers in particular did not show a high intention to use methods for measuring WTP. Skepticism regarding precision of the methods and subjects' capability to imagine paying an amount of money for a certain health commodity were stated along with the assertion that the hypothetical decision-making scenario was rather a distant reality. Nevertheless, the majority of scientists and decision makers did not state rejection of the methods.

Conclusions: Increasing the probability of using methods for measuring WTP in health care, the hypothetical scenarios should be made more realistic and payment vehicles should be used to help patients relate payment to a real health benefit. Moreover, an intensive discussion on the potential usefulness of CV/CE without excluding ethical concerns in comparison to existing alternatives has to be resumed.

Objectives: The aim of this study was to estimate the expected cost and clinical benefits associated with the use of drotrecogin alfa (activated) (Xigris; Eli Lilly and Company; Indianapolis, IN) in the French hospital setting.

Methods: The recombinant human activated PROtein C Worldwide Evaluation in Severe Sepsis (PROWESS) study results (1,271 patients with multiple organ failure) were adjusted to 9,948 hospital stays from a database of Parisian area intensive-care units (ICUs)—the CubRea (Intensive Care Database User Group) database. The analysis features a decision tree with a probabilistic sensitivity analysis.

Results: The cost per life year gained (LYG) of drotrecogin treatment for severe sepsis with multiple organ failure (European indication) was estimated to be $11,812. At the hospital level, the drug is expected to induce an additional cost of $7,545 per treated patient. The incremental cost-effectiveness ratio ranges from $7,873 per LYG for patients receiving three organ supports during ICU stay to $17,704 per LYG for patients receiving less than two organ supports.

Conclusions: Drotrecogin alfa (activated) is cost-effective in the treatment of severe sepsis with multiple organ failure when added to best standard care. The cost-effectiveness of the drug increases with baseline disease severity, but it remains cost-effective for all patients when used in compliance with the European approved indication.

Objectives: The aims of the present study were to investigate the awareness among dentists and dental hygienists of evidence-based reports and guidelines on tobacco cessation activities and the impact these publications had on clinical practice.

Methods: A questionnaire was mailed to dental hygienists and dentists in Stockholm County, Sweden, and the results were compared with a previous investigation.

Results: Among the respondents, awareness of a popular science version of a systematic review on smoking and its effect on oral health was reported by 90 percent of the hygienists and 66 percent of the dentists. The information was used in clinical work by 34 percent of the dentists and 54 percent of the hygienists. Reported changes in patterns of practice were more frequent recommendations to use nicotine replacement therapy and a more widespread use of setting quit dates. Approximately one quarter of the dental professionals reported that they had increased tobacco cessation consultation because of the results from the reports.

Conclusions: Changes in patterns of practice were observed after dissemination of evidence-based information on tobacco cessation. Methods that were proven to be effective in the evidence-based report such as discussing quit dates and recommending nicotine replacement therapy were more commonly used after the publication of the report. Short, popular versions of extensive systematic reviews seem to be useful for implementing evidence-based knowledge and changing clinical practice.

Objectives: The objective of this study is to describe the frequency of inappropriate empirical antibiotic therapy in secondary intra-abdominal infection and to identify the possible relationship between inappropriateness and some clinical outcomes.

Methods: A retrospective descriptive multicenter study was conducted using hospital secondary databases developed at two university hospitals located in northeast Spain. Participants were patients 18 years of age or older who were diagnosed with community-acquired intra-abdominal infections between January 1, 1998, and December 31, 2000, identified through computerized patient records using ICD-9 codes. Appropriateness of empirical treatment was defined according to the recommendations of the literature. The clinical outcome of each patient was classified as one of the following: (i) resolved with initial therapy, (ii) required second-line antibiotics, (iii) required re-operation, or (iv) in-hospital death. The Fisher's exact test or the Chi-squared test for categorical variables and the t-test or Mann–Whitney test for continuous variables were used for comparing groups. Conditional logistic and linear regression analyses were also applied.

Results: Of 376 cases, 51 cases (13.6 percent, 95 percent confidence interval, 10–17 percent) received inappropriate empirical antibiotic therapy according to the scientific literature. Inappropriate initial empirical treatment was significantly associated with the need for a second line of antibiotics (p<.001), although not with re-operation, mortality, or length of hospitalization.

Conclusions: Approximately 14 percent of the patients received inappropriate empirical antibiotic treatment. Worse clinical outcomes consistently were observed in the group of patients receiving inappropriate empirical treatment. The appropriateness of antibiotic treatment for a given infection, in light of the availability of clearly defined clinical guidelines is an easily evaluated aspect of the quality of care.

Background: Endoscopic retrograde cholangiopancreatography (ERCP) is considered the gold standard for imaging of the biliary tract but is associated with complications. Less invasive imaging techniques, such as magnetic resonance cholangiopancreatography (MRCP), have a much lower complication rate. The accuracy of MRCP is comparable to that of ERCP, and MRCP may be more effective and cost-effective, particularly in cases for which the suspected prevalence of disease is low and further intervention can be avoided. A model was constructed to compare the effectiveness and cost-effectiveness of MRCP and ERCP in patients with a previous history of cholecystectomy, presenting with abdominal pain and/or abnormal liver function tests.

Methods: Diagnostic accuracy estimates came from a systematic review of MRCP. A decision analytic model was constructed to represent the diagnostic and treatment pathway of this patient group. The model compared the following two diagnostic strategies: (i) MRCP followed with ERCP if positive, and then management based on ERCP; and (ii) ERCP only. Deterministic and probabilistic analyses were used to assess the likelihood of MRCP being cost-effective. Sensitivity analyses examined the impact of prior probabilities of common bile duct stones (CBDS) and test performance characteristics. The outcomes considered were costs, quality-adjusted life years (QALYs), and cost per additional QALY.

Results: The deterministic analysis indicated that MRCP was dominant over ERCP. At prior probabilities of CBDS, less than 60 percent MRCP was the less costly initial diagnostic test; above this threshold, ERCP was less costly. Similarly, at probabilities of CBDS less than 68 percent, MRCP was also the more effective strategy (generated more QALYs). Above this threshold, ERCP became the more effective strategy. Probabilistic sensitivity analyses indicated that, in this patient group for which there is a low to moderate probability of CBDS, there was a 59 percent likelihood that MRCP was cost-saving, an 83 percent chance that MRCP was more effective with a higher quality adjusted survival, and an 83 percent chance that MRCP had a cost-effectiveness ratio more favorable than $50,000 per QALY gained.

Conclusions: Costs and cost-effectiveness are dependent upon the prior probability of CBDS. However, probabilistic analysis indicated that, with a high degree of certainty, MRCP was the more effective and cost-effective initial test in postcholecystectomy patients with a low to moderate probability of CBDS.

Objectives: An economic evaluation was performed of empirical antisecretory therapy versus test for Helicobacter pylori in the management of dyspepsia patients presenting in primary care.

Methods: A randomized trial in 106 general practices in the County of Funen, Denmark, was designed to include prospective collection of clinical outcome measures and resource utilization data. Dyspepsia patients (n=722) presenting in general practice with more than 2 weeks of epigastric pain or discomfort were managed according to one of three initial management strategies: (i) empirical antisecretory therapy, (ii) testing for Helicobacter pylori, or (iii) empirical antisecretory therapy, followed by Helicobacter pylori testing if symptoms improved. Cost-effectiveness and incremental cost-effectiveness ratios of the strategies were determined.

Results: The mean proportion of days without dyspeptic symptoms during the 1-year follow-up was 0.59 in the group treated with empirical antisecretory therapy, 0.57 in the H. pylori test-and-eradicate group, and 0.53 in the combination group. After 1 year, 23 percent, 26 percent, and 22 percent, respectively, were symptom-free. Applying the proportion of days without dyspeptic symptoms, the cost-effectiveness for empirical treatment, H. pylori test and the combination were 12,131 Danish kroner (DKK), 9,576 DKK, and 7,301 DKK, respectively. The incremental cost-effectiveness going from the combination strategy to empirical antisecretory treatment or H. pylori test alone was 54,783 DKK and 39,700 DKK per additional proportion of days without dyspeptic symptoms.

Conclusions: Empirical antisecretory therapy confers a small insignificant benefit but costs more than strategies based on test for H. pylori and is probably not a cost-effective strategy for the management of dyspepsia in primary care.

The Health Evidence Network (HEN) was established approximately 3 years ago as a service to the health policy makers in the fifty-two member states of World Health Organization (WHO) Europe. The objective of the HEN is to (i) make it easier for policy makers to access evidence-based studies in the field of health, and to (ii) provide synthesis of available evidence around specific policy issues in health.

Objectives: The relatively high cost of information technology systems may be a barrier to hospitals thinking of adopting this technology. The experiences of early adopters may facilitate decision making for hospitals less able to risk their limited resources. This study identifies the costs to design, develop, implement, and operate an innovative informatics-based registry and disease management system (POPMAN) to manage type 2 diabetes in a primary care setting.

Methods: The various cost components of POPMAN were systematically identified and collected.

Results: POPMAN cost $450,000 to develop and operate over 3.5 years (1999–2003). Approximately $250,000 of these costs are one-time expenditures or sunk costs. Annual operating costs are expected to range from $90,000 to $110,000 translating to approximately $90 per patient for a 1,200 patient registry.

Conclusions: The cost of POPMAN is comparable to the costs of other quality-improving interventions for patients with diabetes. Modifications to POPMAN for adaptation to other chronic diseases or to interface with new electronic medical record systems will require additional investment but should not be as high as initial development costs. POPMAN provides a means of tracking progress against negotiated quality targets, allowing hospitals to negotiate pay for performance incentives with insurers that may exceed the annual operating cost of POPMAN. As a result, the quality of care of patients with diabetes through use of POPMAN could be improved at a minimal net cost to hospitals.

Objectives: Industrial management principles could be used to improve the quality and efficiency of health care. In this study, we have evaluated the effects of a process management approach to trauma patient care. The major objective was to reduce the waiting times and increase the efficiency of the hospital.

Methods: Urgent surgery care was analyzed as an overall process. The process development followed the Plan-Do-Check-Act (PDCA) cycle and was based on statistical analysis of certain performance metrics. Data were collected from hospital databases and by personnel interviews. To develop the process, the anesthesia induction was performed outside the operating room, better process guidance was developed, and patient flow was reorganized. The transition time for these changes was 1 year (2002 to 2003).

Results: Waiting times decreased by 20.5 percent (p<.05), nonoperative times in the operating room were reduced by 23.1 percent (p<.001), and efficiency was increased by 9.7 percent (p<.001) after reengineering of the care process. Overtime hours decreased by 30.9 percent.

Conclusions: Managing urgent surgical care as a process can improve the productivity and quality of care without a need to increase personnel resources. The focus should be on reducing waiting times and waste times.

Objectives: The aim of this study was to demonstrate the best way of identifying all relevant published health economic evaluation studies, which have increased in number rapidly in the past few decades. Nevertheless, health technology assessment projects are often faced with a scarcity of relevant studies.

Methods: Six bibliographic databases were searched using various individually adapted strategies. The particular example involves the cost-effectiveness of diagnosing gastroesophageal reflux disease. Inclusion and exclusion criteria were formulated.

Results: After irrelevant studies and duplicates had been excluded, sixty-eight abstracts were reviewed. We chose forty-one of them as relevant for full-text review, which identified fourteen papers as having met the inclusion criteria. Most of the relevant studies were identified by searching the National Health Service Economic Evaluation Database (NHS EED) and PubMed databases.

Conclusions: A search in NHS EED, by means of the Cochrane Library or the Center for Reviews and Dissimination, along with a supplementary search in PubMed, is generally an appropriate, cost-effective strategy. However, because “cost-effectiveness” is not consistently indexed with Medical Subject Heading terms in PubMed, all economic search terms need to be used to fully identify the relevant references.

Objectives: Erectile dysfunction (ED) is a complex condition, which is variously influenced by physical, emotional, societal, and relationship factors. ED has serious implications for the quality of life (QoL) enjoyed by an affected male and his partner. It is very important, therefore, to understand the impact of ED on the QoL of those affected by it. Our objective was to determine if the eight-question Patient Reported Erectile Function Assessment (PREFA) could act as an independent, comprehensive disease-specific instrument in the assessment of QoL as it is impacted by ED.

Methods: During the development and validation of the Erectile Function–Visual Analog Scale (EF-VAS) (14), a new ED-specific preference-based instrument, a series of questions were included at the beginning of the assessment that would act as a way to encourage respondents to focus on their own experience with ED. Upon analysis of the EF-VAS data, it became apparent that the eight-question “warm up” section might act as a stand-alone assessment. Accordingly, the eight questions were named PREFA, and a validation analysis was undertaken to determine their consistency, feasibility, reliability, validity, and responsiveness.

Results: The PREFA questionnaire was found to be feasible and simple to complete, reliable, and valid, with excellent responsiveness. Overall, the PREFA has demonstrated that it can perform as a stand alone, validated assessment of the impact of ED on QoL, assessing areas of QoL not previously captured in existing instruments.

Conclusions: The PREFA is suitable for use in clinical and research settings as a disease-specific QoL assessment tool.

Objectives: This study sought to examine the safety, efficacy, and economic implications of the use of cerebral protection devices during carotid artery angioplasty and stenting (CAS) in high-risk patients with severe carotid artery disease (CAD).

Methods: A comprehensive search for peer- and non–peer-reviewed studies that compared carotid endarterectomy (CEA) or CAS without cerebral protection to CAS with cerebral protection and appeared in the English language literature between January 1990 and January 2005 was completed. Information from studies identified was extracted using a common data abstraction form and then critically appraised against published quality assessment criteria.

Results: Of the eight studies found, six provided information on technical or procedural success rates, with values ranging from 95.6 percent to 100 percent. Three of the four studies comparing groups of patients who received CAS with cerebral protection with those who received only CAS reported a non-statistically significantly higher 30-day incidence of death and stroke (major or minor) in the latter group. None of the three studies comparing CAS with cerebral protection to CEA demonstrated a statistically significant difference in the 30-day incidence of death, major stroke, or myocardial infarction between treatment groups. No economic analyses were found.

Conclusions: In high-risk patients with severe CAD, the evidence suggests that CAS with cerebral protection may offer a safe and efficacious alternative to CEA, reducing the risk of embolic peri-procedural complications associated with CAS to acceptable levels.