Management of patients with intermittent claudication

Intermittent claudication is the first and mildest manifestation of peripheral arterial disease, caused by the atherosclerotic process of progressive narrowing of one or more of the arteries of the peripheral circulation.1 If the arterial system fails, it results in a progressive oxygen debt, experienced by the patient as cramping muscle pain during walking or other physical activity, which forces the patient to pause. The incidence of intermittent claudication increases with age, especially among men, with an annual incidence rate of 0.7%, 3.9%, and 10.6% among 35-44 year, 45-54 year, and 55-64 year old men respectively.2 In women, the incidence rates are approximately 50% lower than in men.2 The development of intermittent claudication is accelerated by the same cardiovascular risk factors as known for other expressions of atherosclerotic disease (i.e. coronary heart disease and cerebro-vascular disease). These risk factors are smoking, diabetes mellitus, hypertension, and hyperlipidaemia

An empirical study of how the Dutch healthcare regulator first formulates the concept of trust and then puts it into practice

Background: Responsive regulation assumes that the parties being regulated are trustworthy and motivated by social responsibility. This assumes that regulation based upon trust will improve the regulated organization more effectively than other regulation models. The purpose of our qualitative study was to unravel the most important elements of trust in the inspectee which can support the inspector’s work and to develop a model and a framework of trust that can be used by the inspectors to legitimize their trust in the inspectee. Methods: We conducted an empirical study on trust regarding the regulation of care services to reveal how trust in the inspectee is conceptualized and assessed. Based on literature and empirical research, we synthesized the concept of trust into six elements, five regarding behavior, and a sixth looking at information about its context. We developed a practical framework for the concept to reduce the conceptual ambiguity, strengthen regulatory assessment, and support appropriate tailoring of the regulatory response. Results: Six elements with respect to trust emerged from the data: showing integrity; transparency; ability to learn; accepting feedback; showing actual change in behavior; context information. These five behavioral elements, plus the context information were merged into a Framework of Trust and designed into an interactive PDF document. Conclusions: This study has sought to address a gap in the empirical knowledge regarding the assessment of trust in the inspectee. The results aim to inform and clarify the regulatory conceptualization and understanding of trust in the inspectee. Other inspectorates may learn from these results for their own practice and explore whether operational deployment of our Framework of Trust effects their assessment and enforcement strategies. Keywords: Trust, Regulation, Inspector, Inspectee, Behavior, Contex

Value of the duplex waveform at the common femoral artery for diagnosing obstructive aortoiliac disease

PurposeTo evaluate the accuracy, predictive value, and observer agreement of the duplex ultrasound waveform at the common femoral artery as a marker of significant aortoiliac disease in a large group of consecutive patients who underwent a diagnostic workup for peripheral arterial disease in a vascular unit.MethodsIn 191 consecutive patients (381 aortoiliac segments), we classified the duplex ultrasound waveform at the common femoral artery as triphasic, biphasic, sharp monophasic, or poor monophasic. The waveforms were then compared with the findings of magnetic resonance angiography of the aortoiliac segment and peripheral runoff vessels. We calculated the diagnostic accuracy of the duplex waveform for detecting >50% obstructive disease of the aortoiliac segment and determined the observer agreement for classifying the duplex waveforms done by two independent observers.ResultsMagnetic resonance angiography showed obstruction in 152 (39.9%) of 381 aortoiliac segments in 191 patients. The presence of a poor monophasic waveform, encountered in 91 (24.3%) of 375 segments, was a reliable sign of significant aortoiliac disease, with a positive predictive value of 92%. Other waveforms were nondiagnostic for aortoiliac obstructive disease. The sharp monophasic waveform reliably predicted occlusive disease of the superficial femoral artery that was seen in 17 of 23 instances. There was good observer agreement for classifying duplex waveforms (κw= 0.85; 95% confidence interval, 0.80 to 0.89).ConclusionThe poor monophasic duplex waveform at the common femoral artery is in itself an accurate marker of aortoiliac obstructive disease. Other waveforms are nondiagnostic for aortoiliac disease

Cost-effectiveness of endovascular revascularization compared to supervised hospital-based exercise training in patients with intermittent claudication: A randomized controlled trial

BackgroundThe optimal first-line treatment for intermittent claudication is currently unclear.ObjectiveTo compare the cost-effectiveness of endovascular revascularization vs supervised hospital-based exercise in patients with intermittent claudication during a 12-month follow-up period.DesignRandomized controlled trial with patient recruitment between September 2002-September 2006 and a 12-month follow-up per patient.SettingA large community hospital.ParticipantsPatients with symptoms of intermittent claudication due to an iliac or femoro-popliteal arterial lesion (293) who fulfilled the inclusion criteria (151) were recruited. Excluded were, for example, patients with lesions unsuitable for revascularization (iliac or femoropopliteal TASC-type D and some TASC type-B/C.InterventionParticipants were randomly assigned to endovascular revascularization (76 patients) or supervised hospital-based exercise (75 patients).MeasurementsMean improvement of health-related quality-of-life and functional capacity over a 12-month period, cumulative 12-month costs, and incremental costs per quality-adjusted life year (QALY) were assessed from the societal perspective.ResultsIn the endovascular revascularization group, 73% (55 patients) had iliac disease vs 27% (20 patients) femoral disease. Stents were used in 46/71 iliac lesions (34 patients) and in 20/40 femoral lesions (16 patients). In the supervised hospital-based exercise group, 68% (51 patients) had iliac disease vs 32% (24 patients) with femoral disease. There was a non-significant difference in the adjusted 6- and 12-month EuroQol, rating scale, and SF36-physical functioning values between the treatment groups. The gain in total mean QALYs accumulated during 12 months, adjusted for baseline values, was not statistically different between the groups (mean difference revascularization versus exercise 0.01; 99% CI −0.05, 0.07; P = .73). The total mean cumulative costs per patient was significantly higher in the revascularization group (mean difference €2318; 99% CI €2130, € 2506; P < .001) and the incremental cost per QALY was 231 800 €/QALY adjusted for the baseline variables. One-way sensitivity analysis demonstrated improved effectiveness after revascularization (mean difference 0.03; CI 0.02, 0.05; P < .001), making the incremental costs 75 208 €/QALY.ConclusionIn conclusion, there was no significant difference in effectiveness between endovascular revascularization compared to supervised hospital-based exercise during 12-months follow-up, any gains with endovascular revascularization found were non-significant, and endovascular revascularization costs more than the generally accepted threshold willingness-to-pay value, which favors exercise

Percutaneous transhepatic biliary drainage in patients with postsurgical bile leakage and nondilated intrahepatic bile ducts

Objective and Background: Bile leakage is a serious postoperative complication and percutaneous transhepatic biliary drainage (PTBD) may be an option when endoscopic treatment is not feasible. In this retrospective study, we established technical and clinical success rates as well as the complication rates of PTBD in a large group of patients with postoperative bile leakage. Methods: Data on all patients with nondilated intrahepatic bile ducts who underwent a PTBD procedure for the treatment of bile leakage between January 2000 and August 2012 were retrospectively assessed. Data included type of surgery, site of bile leak, previous attempts of bile leak repair, interval between surgery and PTBD placement. Outcome measures were the technical and clinical success rates, the procedure-related complications, and mortality rate. Results: A total of 63 patients were identified; PTBD placement was technically successful in 90.5% (57/63) after one to three attempts. The clinical success rate was 69.8% (44/63). Four major complications were documented (4/63; 6.3%): liver laceration, pneumothorax, pleural empyema, and prolonged hemobilia. One minor complication involved pain. Conclusion

Cost-effectiveness of new cardiac and vascular rehabilitation strategies for patients with coronary artery disease

Objective: Peripheral arterial disease (PAD) often hinders the cardiac rehabilitation program. The aim of this study was evaluating the relative cost-effectiveness of new rehabilitation strategies which include the diagnosis and treatment of PAD in patients with coronary artery disease (CAD) undergoing cardiac rehabilitation. Data Sources: Best-available evidence was retrieved from literature and combined with primary data from 231 patients. Methods: We developed a Markov decision model to compare the following treatment strategies: 1. cardiac rehabilitation only; 2. ankle-brachial index (ABI) if cardiac rehabilitation fails followed by diagnostic work-up and revascularization for PAD if needed; 3. ABI prior to cardiac rehabilitation followed by diagnostic work-up and revascularization for PAD if needed. Quality-adjusted-life years (QALYs), life-time costs (US $), incremental cost-effectiveness ratios (ICER), and gain in net health benefits (NHB) in QALY equivalents were calculated. A threshold willingness-to-pay of$75 000 was used. Results: ABI if cardiac rehabilitation fails was the most favorable strategy with an ICER of $44 251 per QALY gained and an incremental NHB compared to cardiac rehabilitation only of 0.03 QALYs (95$75 000/ QALY. After sensitivity analysis, a combined cardiac and vascular rehabilitation program increased the success rate and would dominate the other two strategies with total lifetime costs of $30 246 a quality-adjusted life expectancy of 3.84 years, and an incremental NHB of 0.06 QALYs (95%CI:-0.24, 0.46) compared to current practice. The results were robust for other different input parameters. Conclusion: ABI measurement if cardiac rehabilitation fails followed by a diagnostic work-up and revascularization for PAD if needed are potentially cost-effective compared to cardiac rehabilitation only

Cost-Effectiveness of New Cardiac and Vascular Rehabilitation Strategies for Patients with Coronary Artery Disease

Objective: Peripheral arterial disease (PAD) often hinders the cardiac rehabilitation program. The aim of this study was evaluating the relative cost-effectiveness of new rehabilitation strategies which include the diagnosis and treatment of PAD in patients with coronary artery disease (CAD) undergoing cardiac rehabilitation. Data Sources: Best-available evidence was retrieved from literature and combined with primary data from 231 patients. Methods: We developed a Markov decision model to compare the following treatment strategies: 1. cardiac rehabilitation only; 2. ankle-brachial index (ABI) if cardiac rehabilitation fails followed by diagnostic work-up and revascularization for PAD if needed; 3. ABI prior to cardiac rehabilitation followed by diagnostic work-up and revascularization for PAD if needed. Quality-adjusted-life years (QALYs), life-time costs (US $), incremental cost-effectiveness ratios (ICER), and gain in net health benefits (NHB) in QALY equivalents were calculated. A threshold willingness-to-pay of$75 000 was used. Results: ABI if cardiac rehabilitation fails was the most favorable strategy with an ICER of $44 251 per QALY gained and an incremental NHB compared to cardiac rehabilitation only of 0.03 QALYs (95$75 000/QALY. After sensitivity analysis, a combined cardiac and vascular rehabilitation program increased the success rate and would dominate the other two strategies with total lifetime costs of $30 246 a quality-adjusted life expectancy of 3.84 years, and an incremental NHB of 0.06 QALYs (95%CI:−0.24, 0.46) compared to current practice. The results were robust for other different input parameters. Conclusion: ABI measurement if cardiac rehabilitation fails followed by a diagnostic work-up and revascularization for PAD if needed are potentially cost-effective compared to cardiac rehabilitation only

Der Gebrauch kausativer Konstruktionen mit lassen, bei denen Menschen das Subjekt darstellen : anhand von Beispielen aus Thomas Manns'Doktor Faustus'(1. Teil)

Background: The use of intravenous lipid emulsions in preterm infants has been limited by concerns regarding impaired lipid tolerance. As a result, the time of initiation of parenteral lipid infusion to very-low-birth-weight (VLBW) infants varies widely among different neonatal intensive care units. However, lipids provide energy for protein synthesis and supply essential fatty acids that are necessary for central nervous system development. Objective: The objective was to summarize the effects of initiation of lipids within the first 2 d of life and the effects of different lipid compositions on growth and morbidities in VLBW infants. Design: A systematic review and meta-analysis of publications identified in a search of PubMed, EMBASE, and Cochrane databases was undertaken. Randomized controlled studies were eligible if information on growth was available. Results: The search yielded 14 studies. No differences were observed in growth or morbidity with early lipid initiation. We found a weak favorable association of non-purely soybean-based emulsions with the incidence of sepsis (RR: 0.75; 95% CI: 0.56, 1.00). Conclusions: The initiation of lipids within the first 2 d of life in VLBW infants appears to be safe and well tolerated; however, beneficial effects on growth could not be shown for this treatment nor for the type of lipid emulsion. Emulsions that are not purely soybean oil-based might be associated with a lower incidence of sepsis. Large-scale randomized controlled trials in preterm infants are warranted to determine whether early initiation of lipids and lipid emulsions that are not purely soybean oil-based results in improved long-term outcomes. Am J Clin Nutr 2012;96:255-6