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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. Conclusions

OBJECTIVE. In breast cancer patients eligible for breast-conserving surgery, we evaluated whether the information provided by preoperative MRI of the breast would result in fewer tumor-positive resection margins and fewer reoperations. SUBJECTS AND METHODS. The study group consisted of 123 consecutive patients diagnosed with either breast cancer or ductal carcinoma in situ eligible for breast-conserving surgery between April 2007 and July 2010. For these patients, a first plan for breast-conserving surgery was made on the basis of clinical examination and conventional imaging. The final surgical plan was made with knowledge of the preoperative breast MRI. The rates of tumor-positive resection margins and reoperations were compared with those of a historical control group consisting of 119 patients who underwent 123 breast-conserving procedures between January 2005 and December 2006. The percentage of change in the surgical plan was recorded. RESULTS. Preoperative breast MRI changed the surgical plan to more extensive surgery in 42 patients (34.1%), mainly to mastectomy (29 patients, 23.6%). Ninety-four patients underwent 95 breast-conserving procedures. Significantly fewer patients had tumor-positive resection margins than in the control group (15.8%, 15/95 versus 29.3%, 36/123; p < 0.01). Patients in the study group underwent significantly fewer reoperations compared with the historical control group (18.9%, 18/95 vs 37.4%, 46/123; p < 0.01). CONCLUSION. Preoperative breast MRI can substantially decrease the rate of tumor-positive resection margins and reoperations in breast cancer patients eligible for breast-conserving surgery.

Objective Over the past decade, the availability of biological agents for the treatment of juvenile idiopathic arthritis ( JIA) has increased substantially. Because direct head-to-head trials comparing these agents are lacking, we indirectly compared their efficacy. Methods In a systematic review, all available efficacy data from randomised controlled trials performed in JIA with inclusion of biological agents were retrieved. Indirect between-drug comparisons (based on Bucher’s method) were conducted only if trials were comparable with regard to design and patients’ characteristics related to treatment outcome. Results We identified 11 randomised controlled trials. On the basis of the equality of the trials, six trials were grouped into two networks of evidence. Network 1 included withdrawal trials which evaluated etanercept, adalimumab and abatacept in polyarticular course JIA. Indirect comparisons identified no significant differences in short-term efficacy. Network 2 indirectly compared trials with a parallel study design investigating anakinra, tocilizumab and canakinumab in systemic JIA; no differences in comparative efficacy were identified. Although the two networks were constructed on the basis of comparability, small differences in trial design and case mix still existed. Conclusions Because of the small number of trials and the observed differences between trials, no definite conclusions could be drawn about the comparative effectiveness of the indirectly compared biological agents. Therefore, for now, the paediatric rheumatologist has to rely on observational data and safety, practical and financial arguments. Comparability of future trials needs to be improved, and head-to-head trials are required to decide on the best biological treatment for JIA.

Purpose. Modeling studies that evaluate statin treatment for the prevention of cardiovascular disease (CVD) use different methods to model the effect of statins. The aim of this study was to evaluate the impact of using different modeling methods on the optimal decision found in such studies. Methods. We used a previously developed and validated Monte Carlo-Markov model based on the Rotterdam study (RISC model). The RISC model simulates coronary heart disease (CHD), stroke, cardiovascular death, and death due to other causes. Transition probabilities were based on 5-year risks predicted by Cox regression equations, including (among others) total and high-density lipoprotein (HDL) cholesterol as covariates. In a cost-effectiveness analysis of implementing the ATP-III guidelines, we evaluated the impact of using 3 different modeling methods of statin effectiveness: 1) through lipid level modification: statins lower total cholesterol and increase HDL cholesterol, which through the covariates in the Cox regression equations leads to a lower incidence of CHD and stroke events; 2) fixed risk reduction of CVD events: statins decrease the odds of CHD and stroke with an associated odds ratio that is assumed to be the same for each individual; 3) risk reduction of CVD events proportional to individual change in low-density lipoprotein (LDL) cholesterol: the relative risk reduction with statin therapy on the incidence of CHD and stroke was assumed to be proportional to the absolute reduction in LDL cholesterol levels for each individual. The probability that the ATP-III strategy was cost-effective, compared to usual care as observed in the Rotterdam study, was calculated for each of the 3 modeling methods for varying willingness-to-pay thresholds. Results. Incremental cost-effectiveness ratios for the ATP-III strategy compared with the reference strategy were €56,642/quality-adjusted life year (QALY), €21,369/QALY, and €22,131/QALY for modeling methods 1, 2, and 3, respectivel

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.

Intermittent claudication (IC) has a high prevalence in the older population and is closely associated with cardiovascular and cerebrovascular disease. High mortality rates are reported due to ongoing atherosclerotic disease. Because of these serious health risks, treatment of IC should address reduction of cardiovascular events (and related morbidity/mortality) and improvement of the poor health-related quality of life (QoL) and functional capacity. In several randomized clinical trials and systematic reviews, supervised exercise therapy (SET) is compared with non-supervised exercise, usual care, placebo, walking advice or vascular interventions. The current evidence supports SET as the primary treatment for IC. SET improves maximum walking distance and health-related QoL with a marginal risk of co-morbidity or mortality. This is also illustrated in contemporary international guidelines. Community-based SET appears to be at least as efficacious as programs provided in a clinical setting. In the Netherlands, a national integrated care network (ClaudicatioNet) providing specialized care for patients with IC is currently being implemented. Besides providing a standardized form of SET, the specialized physical therapists stimulate medication compliance and perform lifestyle coaching. Future research should focus on the influence of co-morbidities on prognosis and effect of SET outcome and the potential beneficial effects of SET combined with a vascular intervention.

Background: Physicians need to inform asymptomatic individuals about personalized outcomes of statin therapy for primary prevention of cardiovascular disease (CVD). However, current prediction models focus on short-term outcomes and ignore the competing risk of death due to other causes. We aimed to predict the potential lifetime benefits with statin therapy, taking into account competing risks. Methods and Findings: A microsimulation model based on 5-y follow-up data from the Rotterdam Study, a population-based cohort of individuals aged 55 y and older living in the Ommoord district of Rotterdam, the Netherlands, was used to estimate lifetime outcomes with and without statin therapy. The model was validated in-sample using 10-y follow-up data. We used baseline variables and model output to construct (1) a web-based calculator for gains in total and CVD-free life expectancy and (2) color charts for comparing these gains to the Systematic Coronary Risk Evaluation (SCORE) charts. In 2,428 participants (mean age 67.7 y, 35.5% men), statin therapy increased total life expectancy by 0.3 y (SD 0.2) and CVD-free life expectancy by 0.7 y (SD 0.4). Age, sex, smoking, blood pressure, hypertension, lipids, diabetes, glucose, body mass index, waist-to-hip ratio, and creatinine were included in the calculator. Gains in total and CVD-free life expectancy increased with blood pressure, unfavorable lipid levels, and body mass index after multivariable adjustment. Gains decreased considerably with advancing age, while SCORE 10-y CVD mortality risk increased with age. Twenty-five percent of participants with a low SCORE risk achieved equal or larger gains in CVD-free life expectancy than the median gain in participants with a high SCORE risk. Conclusions: We developed tools to predict personalized increases in total and CVD-free life expectancy with statin therapy. The predicted gains we found are small. If the underlying model is validated in an independent cohort, the tools may be

The performance of a diagnostic test is often expressed in terms of sensitivity and specificity compared with the reference standard. Calculations of sensitivity and specificity commonly involve multiple observations per patient, which implies that the data are clustered. Whether analysis of sensitivity and specificity per patient or using multiple observations per patient is preferable depends on the clinical context and consequences. The purpose of this article was to discuss and illustrate the most common statistical methods that calculate sensitivity and specificity of clustered data, adjusting for the possible correlation between observations

Objectives: The aim of this study was to assess the (cost-) effectiveness of screening asymptomatic individuals at intermediate risk of coronary heart disease (CHD) for coronary artery calcium with computed tomography (CT). Background: Coronary artery calcium on CT improves prediction of CHD. Methods: A Markov model was developed on the basis of the Rotterdam Study. Four strategies were evaluated: 1) current practice; 2) current prevention guidelines for cardiovascular disease; 3) CT screening for coronary calcium; and 4) statin therapy for all individuals. Asymptomatic individuals at intermediate risk of CHD were simulated over their remaining lifetime. Quality-adjusted life years (QALYs), costs, and incremental cost-effectiveness ratios were calculated. Results: In men, CT screening was more effective and more costly than the other 3 strategies (CT vs. current practice: +0.13 QALY [95% confidence interval (CI): 0.01 to 0.26], +$4,676 [95% CI: $3,126 to $6,339]; CT vs. statin therapy: +0.04 QALY [95% CI: -0.02 to 0.13], +$1,951 [95% CI: $1,170 to $2,754]; and CT vs. current guidelines: +0.02 QALY [95% CI: -0.04 to 0.09], +$44 [95% CI: -$441 to $486]). The incremental cost-effectiveness ratio of CT calcium screening was $48,800/QALY gained. In women, CT screening was more effective and more costly than current practice (+0.13 QALY [95% CI: 0.02 to 0.28], +$4,663 [95% CI: $3,120 to $6,277]) and statin therapy (+0.03 QALY [95% CI: -0.03 to 0.12], +$2,273 [95% CI: $1,475 to $3,109]). However, implementing current guidelines was more effective compared with CT screening (+0.02 QALY [95% CI: -0.03 to 0.07]), only a little more expensive (+$297 [95% CI: -$8 to $633]), and had a lower cost per additional QALY ($33,072/QALY vs. $35,869/QALY). Sensitivity analysis demonstrated robustness of results in women but considerable uncertainty in men. Conclusions: Screening for coronary artery calcium with CT in individuals at intermediate risk of CHD is probably cost-effective in m

Objectives: The aim of this study was to assess the (cost-) effectiveness of screening asymptomatic individuals at intermediate risk of coronary heart disease (CHD) for coronary artery calcium with computed tomography (CT). Background: Coronary artery calcium on CT improves prediction of CHD. Methods: A Markov model was developed on the basis of the Rotterdam Study. Four strategies were evaluated: 1) current practice; 2) current prevention guidelines for cardiovascular disease; 3) CT screening for coronary calcium; and 4) statin therapy for all individuals. Asymptomatic individuals at intermediate risk of CHD were simulated over their remaining lifetime. Quality-adjusted life years (QALYs), costs, and incremental cost-effectiveness ratios were calculated. Results: In men, CT screening was more effective and more costly than the other 3 strategies (CT vs. current practice: +0.13 QALY [95% confidence interval (CI): 0.01 to 0.26], +$4,676 [95% CI: $3,126 to $6,339]; CT vs. statin therapy: +0.04 QALY [95% CI: -0.02 to 0.13], +$1,951 [95% CI: $1,170 to $2,754]; and CT vs. current guidelines: +0.02 QALY [95% CI: -0.04 to 0.09], +$44 [95% CI: -$441 to $486]). The incremental cost-effectiveness ratio of CT calcium screening was $48,800/QALY gained. In women, CT screening was more effective and more costly than current practice (+0.13 QALY [95% CI: 0.02 to 0.28], +$4,663 [95% CI: $3,120 to $6,277]) and statin therapy (+0.03 QALY [95% CI: -0.03 to 0.12], +$2,273 [95% CI: $1,475 to $3,109]). However, implementing current guidelines was more effective compared with CT screening (+0.02 QALY [95% CI: -0.03 to 0.07]), only a little more expensive (+$297 [95% CI: -$8 to $633]), and had a lower cost per additional QALY ($33,072/QALY vs. $35,869/QALY). Sensitivity analysis demonstrated robustness of results in women but considerable uncertainty in men. Conclusions: Screening for coronary artery calcium with CT in individuals at intermediate risk of CHD is probably cost-effective in m

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.

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.

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% CI: -0.17, 0.29) at a threshold willingness-topay of $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.