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Skin reactions occur frequently during and after treatment of actinic keratosis (AK) with 5% 5-Fluorouracil (5-FU). Managing expectations is important to prevent patients from prematurely terminating treatment and to ensure patients' adherence. The frequency and severity of skin reactions was evaluated with data from patients with AK who participated in a clinical trial comparing different field-directed therapies for AK and were randomized to 5-FU cream.1 A secondary objective was to evaluate whether more severe skin reactions were associated with a higher probability of treatment success.

Summary Background Actinic keratosis (AK) is a common premalignant skin condition that might have the ability to progress into squamous cell carcinoma. Due to the high incidence of AK, treatment of this disease significantly impacts healthcare spending. Objectives To determine which commonly prescribed field‐directed treatment is the most cost‐effective, when comparing 5‐fluorouracil (5‐FU) 5%, imiquimod (IMQ) 5%, ingenol mebutate (IM) 0·015% and methyl aminolaevulinate photodynamic therapy (MAL‐PDT) for AK in the head and neck region. Methods We performed an economic evaluation from a healthcare perspective. Data were collected alongside a single‐blinded, prospective, multicentre randomized controlled trial with 624 participants in the Netherlands. The outcome measure was expressed as the incremental cost‐effectiveness ratio, which is the incremental costs per additional patient with ≥ 75% lesion reduction compared with baseline. This trial was registered at ClinicalTrials.gov, number NCT02281682. Results The trial showed that 5‐FU was the most effective field treatment for AK in the head and neck region. Twelve months post‐treatment, the total mean costs for 5‐FU were significantly lower (€433) than the €728, €775 and €1621 for IMQ, IM and MAL‐PDT, respectively. The results showed that 5‐FU was a dominant cost‐effective treatment (more effective and less expensive) compared with the other treatments, 12 months post‐treatment. Conclusions Based on these results, we consider 5‐FU 5% cream as the first‐choice treatment option for multiple AKs in the head and neck area. What's already known about this topic? Due to the increasing incidence of actinic keratosis (AK), the recommended treatment results in a considerable socioeconomic burden for (dermatological) healthcare.Although cost‐effectiveness modelling studies have been performed in which different treatments for AK were compared, a prospective clinical trial comparing four frequently prescribed treatments on effectiveness and resource consumption within a time horizon of 12 months has never been conducted. What does this study add? This is the first study examining the cost‐effectiveness of 5‐fluorouracil 5% cream, imiquimod 5% cream, ingenol mebutate 0·015% gel and methyl aminolaevulinate photodynamic therapy, with data collected in a randomized controlled trial over a time horizon of 12 months.We found that 5‐fluorouracil was a dominant cost‐effective treatment (more effective and less costly), based on data from the Netherlands. Linked Comment: Steeb et al. Br J Dermatol 2020; 183:612., Linked Comment: Steeb et al. Br J Dermatol 2020; 183:612. Plain language summary available online

Objective Guidelines on safe use of iodinated contrast material recommend intravenous prophylactic hydration to prevent post-contrast adverse (renal) effects. Recently, guidelines have been updated and standard prophylaxis is no longer recommended for the majority of patients. The current study aims to evaluate the consequences for clinical practice of the updated guidelines in terms of complications, hospitalisations, and costs. Methods The Contrast-Induced Nephropathy After Reduction of the prophylaxis Threshold (CINART) project is a retrospective observational study. All elective procedures with intravascular iodinated contrast administration at Maastricht University Medical Centre (UMC+) in patients aged > 18 years, formerly eligible for prophylaxis (eGFR 30–44 ml/min/1.73 m2 or eGFR 45–59 ml/min/1.73 m2 in combination with diabetes or > 1 predefined risk factor), and currently eligible for prophylaxis (eGFR 2) were included. Data were used to calculate relative reductions in complications, hospitalisations, and costs associated with standard prophylactic intravenous hydration. CINART is registered with Clinicaltrials.gov: NCT03227835. Results Between July 1, 2017, and July 1, 2018, 1992 elective procedures with intravascular iodinated contrast in patients formerly and currently eligible for prophylaxis were identified: 1808 in patients formerly eligible for prophylaxis and 184 in patients currently eligible for prophylaxis. At Maastricht UMC+, guideline updates led to large relative reductions in numbers of complications of prophylaxis (e.g. symptomatic heart failure; − 89%), extra hospitalisations (− 93%), and costs (− 91%). Conclusion Guideline updates have had a demonstrable impact on daily clinical practice benefiting patient, hospital, and health care budgets. Clinical practice varies between institutions and countries; therefore, a local estimation model is provided with which local impact on costs, hospitalisations, and complications can be calculated. Key Points • Clinical practice guidelines recommend prophylactic intravenous hydration to prevent post-contrast adverse outcomes such as contrast-induced acute kidney injury. • Clinical practice guidelines have recently been updated, and standard prophylaxis is no longer recommended for the majority of patients. • The guideline updates have a large impact on daily clinical practice: relative reductions at Maastricht UMC+ were − 89% prophylaxis complications, − 93% hospitalisations, and − 91% costs, and similar reductions are expected for Dutch and adherent European medical centres.

Background: The purpose of this study was to investigate the prevalence of ypN+ status according to ypT category in patients with locally advanced rectal cancer treated with chemoradiotherapy and total mesorectal excision, and to assess the impact of ypN+ on disease recurrence and survival by pooled analysis of individual-patient data.Methods: Individual-patient data from 10 studies of chemoradiotherapy for rectal cancer were included. Pooled rates of ypN+ disease were calculated with 95 per cent confidence interval for each ypT category. Kaplan-Meier and Cox regression analyses were undertaken to assess influence of ypN status on 5-year disease-free survival (DFS) and overall survival (OS).Results: Data on 1898 patients were included in the study. Median follow-up was 50 (range 0-219)months. The pooled rate of ypN+ disease was 7 per cent for ypT0, 12 per cent for ypT1, 17 per cent for ypT2, 40 per cent for ypT3, and 46 per cent for ypT4 tumours. Patients with ypN+ disease had lower 5-year DFS and OS (46.2 and 63.4 per cent respectively) than patients with ypN0 tumours (74.5 and 83.2 per cent) (P

Contrast-enhanced mammography (CEM) has shown to be superior to full-field digital mammography (FFDM), but current results are dominated by studies performed on systems by one vendor. Information on diagnostic accuracy of other CEM systems is limited. Therefore, we aimed to evaluate the diagnostic performance of CEM on an alternative vendor’s system. We included all patients who underwent CEM in one hospital in 2019, except those with missing data or in whom CEM was used as response monitoring tool. Three experienced breast radiologists scored the low-energy images using the BI-RADS classification. Next, the complete CEM exams were scored similarly. Histopathological results or a minimum of one year follow-up were used as reference standard. Diagnostic performance and AUC were calculated and compared between low-energy images and the complete CEM examination, for all readers independently as well as combined. Breast cancer was diagnosed in 23.0% of the patients (35/152). Compared to low-energy images, overall CEM sensitivity increased from 74.3 to 87.6% (p p = 0.0146). AUC increased from 0.872 to 0.957 (p = 0.0001). Performing CEM on the system tested, showed that, similar to earlier studies mainly performed on another vendor’s systems, both sensitivity and specificity improved when compared to FFDM.

This is a comment on a network meta-analysis that evaluated the ranking of treatments for actinic keratosis outside the head and neck. The results of a limited number of heterogeneous studies contrast with the results of studies in the head and neck area. The extent to which these results can be generalized to larger treatment fields or areas with extensive field cancerization is uncertain.

Aim. To evaluate the performance of three contrast media (CM) injection protocols for cardiac computed tomography angiography (CCTA) based on body weight (BW), lean BW (LBW), and cardiac output (CO). Materials and methods. A total of 327 consecutive patients referred for CCTA were randomized into one of the three CM injection protocols, where CM injection was based on either BW (112 patients), LBW (108 patients), or CO (107 patients). LBW and CO were calculated via formulas. All scans were ECG-gated and performed on a third-generation dual-source CT with 70–120 kV (automated tube voltage selection) and 100 kVqual.ref/330 mAsqual.ref. CM injection protocols were also adapted to scan time and tube voltage. The primary outcome was the proportion of patients with optimal intravascular attenuation (325–500 HU). Secondary outcomes were mean and standard deviation of intravascular attenuation values (HU), contrast-to-noise ratio (CNR), and subjective image quality with a 4-point Likert scale (1 = poor/2 = sufficient/3 = good/4 = excellent). The t-test for independent samples was used for pairwise comparisons between groups, and a chi-square test (χ2) was used to compare categorical variables between groups. All p values were 2-sided, and a p<0.05 was considered statistically significant. Results. Mean overall HU and CNR were 423 ± 60HU/14 ± 3 (BW), 404 ± 62HU/14 ± 3 (LBW), and 413 ± 63HU/14 ± 3 (CO) with a significant difference between groups BW and LBW (p=0.024). The proportion of patients with optimal intravascular attenuation (325–500 HU) was 83.9%, 84.3%, and 86.9% for groups BW, LBW, and CO, respectively, and between-group differences were small and nonsignificant. Mean CNR was diagnostic (≥10) in all groups. The proportion of scans with good-excellent image quality was 94.6%, 86.1%, and 90.7% in the BW, LBW, and CO groups, respectively. The difference between proportions was significant between the BW and LBW groups. Conclusion. Personalization of CM injection protocols based on BW, LBW, and CO, and scan time and tube voltage in CCTA resulted in low variation between patients in terms of intravascular attenuation and a high proportion of scans with an optimal intravascular attenuation. The results suggest that personalized CM injection protocols based on LBW or CO have no additional benefit when compared with CM injection protocols based on BW.

OBJECTIVE. The purpose of this article is to determine the accuracy of CT in the detection of tumor invasion beyond the bowel wall and nodal involvement of colon carcinomas. A literature search was performed to identify studies describing the accuracy of CT in the staging of colon carcinomas. Studies including rectal carcinomas that were inseparable from colon carcinomas were excluded. Publication bias was explored by using a Deeks funnel plot asymmetry test. A hierarchic summary ROC model was used to construct a summary ROC curve and to calculate summary estimates of sensitivity, specificity, and diagnostic odds ratios (ORs). CONCLUSION. On the basis of a total of 13 studies, pooled sensitivity, specificity, and diagnostic ORs for detection of tumor invasion beyond the bowel wall (T3-T4) were 90% (95% CI, 83-95%), 69% (95% CI, 62-75%), and 20.6 (95% CI, 10.2-41.5), respectively. For detection of tumor invasion depth of 5 mm or greater (T3cd-T4), estimates from four studies were 77% (95% CI, 66-85%), 70% (95% CI, 53-83%), and 7.8 (95% CI, 4.2-14.2), respectively. For nodal involvement (N+), 16 studies were included with values of 71% (95% CI, 5981%), 67% (95% CI, 46-83%), and 4.8 (95% CI, 2.5-9.4), respectively. Two studies using CT colonography were included with sensitivity and specificity of 97% (95% CI, 90-99%) and 81% (95% CI, 65-91%), respectively, for detecting T3-T4 tumors. CT has good sensitivity for the detection of T3-T4 tumors, and evidence suggests that CT colonography increases its accuracy. Discriminating between T1-T3ab and T3cd-T4 cancer is challenging, but data were limited. CT has a low accuracy in detecting nodal involvement.

Purpose To summarize existing evidence of thoracic magnetic resonance (MR) imaging in determining the nodal status of non-small cell lung cancer (NSCLC) with the aim of elucidating its diagnostic value on a per-patient basis (eg, in treatment decision making) and a per-node basis (eg, in target volume delineation for radiation therapy), with results of cytologic and/or histologic examination as the reference standard. Materials and Methods A systematic literature search for original diagnostic studies was performed in PubMed, Web of Science, Embase, and MEDLINE. The methodologic quality of each study was evaluated by using the Quality Assessment of Diagnostic Accuracy Studies 2, or QUADAS-2, tool. Hierarchic summary receiver operating characteristic curves were generated to estimate the diagnostic performance of MR imaging. Subgroup analyses, expressed as relative diagnostic odds ratios (DORs) (rDORs), were performed to evaluate whether publication year, methodologic quality, and/or method of evaluation (qualitative [ie, lesion size and/or morphology] vs quantitative [eg, apparent diffusion coefficients in diffusion-weighted images]) affected diagnostic performance. Results Twelve of 2551 initially identified studies were included in this meta-analysis (1122 patients; 4302 lymph nodes). On a per-patient basis, the pooled estimates of MR imaging for sensitivity, specificity, and DOR were 0.87 (95% confidence interval [CI]: 0.78, 0.92), 0.88 (95% CI: 0.77, 0.94), and 48.1 (95% CI: 23.4, 98.9), respectively. On a per-node basis, the respective measures were 0.88 (95% CI: 0.78, 0.94), 0.95 (95% CI: 0.87, 0.98), and 129.5 (95% CI: 49.3, 340.0). Subgroup analyses suggested greater diagnostic performance of quantitative evaluation on both a per-patient and per-node basis (rDOR = 2.76 [95% CI: 0.83, 9.10], P = .09 and rDOR = 7.25 [95% CI: 1.75, 30.09], P = .01, respectively). Conclusion This meta-analysis demonstrated high diagnostic performance of MR imaging in staging hilar and mediastinal lymph nodes in NSCLC on both a per-patient and per-node basis. (©) RSNA, 2016 Online supplemental material is available for this article.

Essentials Patients with bleeding disorders are at risk of operative bleeding, but screening for these disorders is challenging.Patients with and without bleeding symptoms on a guideline‐based screening questionnaire were included and hemostatically phenotyped.The questionnaire could not differentiate between patients with and without hemostatic abnormalities.The discriminative power of the PT, aPTT, TT, Euglobulin lysis time, PFA, and the ISTH‐BAT was also limited. Background Patients with mild bleeding disorders are at risk of perioperative bleeding, but screening for these disorders remains challenging. Objectives We aimed to assess the prevalence of hemostatic abnormalities in patients with and without reported bleeding symptoms on a preoperative questionnaire, consisting of guideline‐proposed questions, and appraised the diagnostic value of several screening modalities for the identification of patients with hemostatic abnormalities. Methods In this observational study, 240 patients with and 95 patients without bleeding symptoms on the preoperative questionnaire were included. Patients with known bleeding disorders, antithrombotic drugs, thrombocytopenia, and anemia were excluded. Preoperatively, all patients underwent elaborate hemostatic testing. Hemostatic abnormalities were defined as coagulation, vWF, or fibrinolysis factor levels below reference range and platelet function defects. Screening modalities included the ISTH Bleeding Assessment Tool (ISTH‐BAT), PT, aPTT, TT, Euglobulin Lysis Time (ELT), and Platelet Function Analyser (PFA). Results In 21 of 240 (8.8%) patients reporting bleeding symptoms, hemostatic abnormalities were found, including 7 reduced coagulation factor levels, 10 platelet function abnormalities, and 4 reduced vWF levels. In comparison, 10 of 95 (10.5%) patients not reporting bleeding symptoms had abnormalities. The ISTH‐BAT could not identify patients with abnormalities, while PT, aPTT, TT, ELT, and PFA had high specificity but low sensitivity to detect abnormalities. Conclusions The prevalence of hemostatic abnormalities in both patients with and without reported bleeding symptoms was 9%‐10%. This suggests that the guideline‐based questionnaire cannot differentiate between patients with and without abnormalities, while the discriminative power of the screening modalities is also limited.

Objectives: The primary aim was to investigate whether stenting of post-thrombotic iliofemoral obstruction reduces venous hypertension. The secondary aim was to establish whether improvement in haemodynamic parameters impacts on quality of life. Methods: In this prospective observational study, 12 participants with unilateral post-thrombotic obstruction of the iliac and/or common femoral veins (CFVs) underwent a treadmill stress test with invasive pressure measurements in the CFVs and dorsal foot veins of both affected and non-affected limbs. This was performed the day before and 3 months after stenting the obstructed tract. Paired sample t-tests were used to compare the treatment effect and univariable linear regression analysis to determine the association with improvement in quality of life. Results: Before treatment, CFV pressure increased 34.8 +/- 23.1 mmHg during walking in affected limbs compared with 3.9 +/- 5.8 mmHg in non-affected limbs. This pressure rise decreased to 22.3 +/- 24.8 mmHg after 3 months follow up compared with a 4.0 +/- 6.0 mmHg increase in non-affected limbs (-26.2 mmHg difference; 95% CI -41.2 to -11.3).No such effect was found in the dorsal foot veins. The VEINES-QOL increased 25.3 +/- 11.3 points after stenting and was significantly associated with a decrease in CFV pressure rise during walking (regression coefficient 0.4; 95% CI 0.1-0.6). Conclusion: Stenting of post-thrombotic iliofemoral obstruction significantly reduces venous hypertension in the common femoral vein and correlates with an improvement in the quality of life. Larger studies with a broader range of degree of obstruction need be performed to assess whether pre-stenting pressure measurements can predict post stenting clinical success. (C) 2018 European Society for Vascular Surgery. Published by Elsevier B.V. All rights reserved.

Purpose To evaluate the diagnostic performance of unenhanced axillary T2-weighted and diffusion-weighted (DW) magnetic resonance (MR) imaging for axillary nodal staging in patients with newly diagnosed breast cancer, with node-by-node and patient-by-patient validation. Materials and Methods Institutional review board approval and informed consent were obtained. Fifty women (mean age, 60 years; range, 22-80 years) underwent high-spatial-resolution axillary 3.0-T T2-weighted imaging without fat suppression and DW imaging (b = 0, 500, and 800 sec/mm2), followed by either sentinel lymph node biopsy (SLNB) or axillary lymph node dissection. Two radiologists independently scored each lymph node on a confidence level scale from 0 (benign) to 4 (malignant), first on T2-weighted MR images, then on DW MR images. Two researchers independently measured the mean apparent diffusion coefficient (ADC) of each lymph node. Diagnostic performance parameters were calculated on the basis of node-by-node and patient-by-patient validation. Results With respective node-by-node and patient-by-patient validation, T2-weighted MR imaging had a specificity of 93%-97% and 87%-95%, sensitivity of 32%-55% and 50%-67%, negative predictive value (NPV) of 88%-91% and 86%-89%, positive predictive value (PPV) of 60%-70% and 62%-75%, and area under the receiver operating characteristic curve (AUC) of 0.78 and 0.80-0.88, with good interobserver agreement (kappa = 0.70). The addition of DW MR imaging resulted in lower specificity (59%-88% and 50%-84%), higher sensitivity (45%-64% and 75%-83%), comparable NPV (89% and 90%-91%), lower PPV (23%-42% and 34%-60%), and lower AUC (0.68-0.73 and 0.70-0.86). ADC measurement resulted in a specificity of 63%-64% and 61%-63%, sensitivity of 41% and 67%, NPV of 85% and 85%-86%, PPV of 18% and 35%-36%, and AUC of 0.54-0.58 and 0.69-0.74, respectively, with excellent interobserver agreement (intraclass correlation coefficient, 0.83). Conclusion Dedicated high-spatial-resolution axillary T2-weighted MR imaging showed good specificity on the basis of node-by-node and patient-by-patient validation, with good interobserver agreement. However, its NPV is still insufficient to substitute it for SLNB for exclusion of axillary lymph node metastasis. DW MR imaging and ADC measurement were of no added value. (c) RSNA, 2014.

This study was designed to evaluate the feasibility of endovascular guidance by means of live fluoroscopy fusion with magnetic resonance angiography (MRA) and computed tomography angiography (CTA).Fusion guidance was evaluated in 20 endovascular peripheral artery interventions in 17 patients. Fifteen patients had received preinterventional diagnostic MRA and two patients had undergone CTA. Time for fluoroscopy with MRA/CTA coregistration was recorded. Feasibility of fusion guidance was evaluated according to the following criteria: for every procedure the executing interventional radiologists recorded whether 3D road-mapping provided added value (yes vs. no) and whether PTA and/or stenting could be performed relying on the fusion road-map without need for diagnostic contrast-enhanced angiogram series (CEAS) (yes vs. no). Precision of the fusion road-map was evaluated by recording maximum differences between the position of the vasculature on the virtual CTA/MRA images and conventional angiography.Average time needed for image coregistration was 5 +/- A 2 min. Three-dimensional road-map added value was experienced in 15 procedures in 12 patients. In half of the patients (8/17), intervention was performed relying on the fusion road-map only, without diagnostic CEAS. In two patients, MRA roadmap showed a false-positive lesion. Excluding three patients with inordinate movements, mean difference in position of vasculature on angiography and MRA/CTA road-map was 1.86 +/- A 0.95 mm, implying that approximately 95 % of differences were between 0 and 3.72 mm (2 +/- A 1.96 standard deviation).Fluoroscopy with MRA/CTA fusion guidance for peripheral artery interventions is feasible. By reducing the number of CEAS, this technology may contribute to enhance procedural safety.

Light transmission aggregation (LTA) is the gold standard for the diagnosis of platelet function disorders (PFDs), but it is time-consuming and limited to specialized laboratories. Whole-blood impedance aggregometry (Multiplate) and platelet function analyzer (PFA) may be used as rapid screening tools to exclude PFDs. The aim of this study is to assess the diagnostic performance of Multiplate and PFA for PFDs, as detected by LTA.Data from preoperative patients, patients referred to the hematologist for bleeding evaluation, and patients with a diagnosed bleeding disorder were used. PFDs were defined as >= 2 abnormal LTA curves. Diagnostic performance of Multiplate and PFA for detecting PFDs was expressed as sensitivity and specificity. The ability of Multiplate agonists and PFA kits to detect corresponding LTA curve abnormalities was expressed as area under the receiver operating characteristic curve. Prevalence of PFDs was 16/335 (4.8%) in preoperative patients, 10/54 (18.5%) in referred patients, and 3/25 (12%) in patients with a diagnosed bleeding disorder. In preoperative and referred patients, the sensitivity of Multiplate and PFA for detecting mild PFDs varied between 0% and 40% and AUCs for detecting corresponding LTA curve abnormalities were close to 0.50. In patients with a diagnosed bleeding disorder, both assays could detect Glanzmann thrombasthenia (GT) with sensitivity of 100% and AUCs of 0.70-1.00. Multiplate and PFA cannot discriminate between preoperative and referred patients with and without mild PFDs, meaning that they cannot be used as screening tests to rule out mild PFDs in these populations. Both Multiplate and PFA can detect GT in previously diagnosed patients.

Background Patients with Stanford type B aortic dissections (ADs) are at risk of long-term disease progression and late complications. The aim of this study was to evaluate the natural course and evolution of acute type B AD and intramural hematomas (IMHs) in patients who presented without complications during their initial hospital admission and who were treated with optimal medical management (MM). Methods Databases from 2 aortic centers in Europe and the United States were used to identify 136 patients with acute type B AD (n = 92) and acute type B IMH (n = 44) who presented without complications during their index admission and were treated with MM. Computed tomography angiography scans were available at onset (≤14 days) and during follow-up for those patients. Relevant data, including evidence of adverse events during follow-up (AE; defined according to current guidelines), were retrieved from medical records and by reviewing computed tomography scan images. Aortic diameters were measured with dedicated 3-dimensional software. Results The 1-, 2-, and 5-year event-free survival rates of patients with type B AD were 84.3% (95% confidence interval [CI], 74.4-90.6), 75.4% (95% CI, 64.0-83.7), and 62.6% (95% CI, 68.9-73.6), respectively. Corresponding estimates for IMH were 76.5% (95% CI, 57.8-87.8), 76.5% (95% CI, 57.8-87.8), and 68.9% (95% CI, 45.2-83.9), respectively. In patients with type B AD, risk of an AE increased with aortic growth within the first 6 months after onset. A diameter increase of 5 mm in the first half year was associated with a relative risk for AE of 2.29 (95% CI, 1.70-3.09) compared with the median 6 months' growth of 2.4 mm. In approximately 60% of patients with IMH, the abnormality resolved within 12 months and in the patients with nonresolving IMH, risk of an adverse event was greatest in the first year after onset and remained stable thereafter. Conclusions More than one third of patients with initially uncomplicated type B AD suffer an AE under MM within 5 years of initial diagnosis. In patients with nonresolving IMH, most adverse events are observed in the first year after onset. In patients with type B AD an early aortic growth is associated with a greater risk of AE.

Epicardial adipose tissue (EAT) is emerging as a risk factor for coronary artery disease (CAD).The aim of this study was to determine the applicability and efficiency of automated EAT quantification.EAT volume was assessed both manually and automatically in 157 patients undergoing coronary CT angiography. Manual assessment consisted of a short-axis-based manual measurement, whereas automated assessment on both contrast and non-contrast-enhanced data sets was achieved through novel prototype software. Duration of both quantification methods was recorded, and EAT volumes were compared with paired samples t test. Correlation of volumes was determined with intraclass correlation coefficient; agreement was tested with Bland-Altman analysis. The association between EAT and CAD was estimated with logistic regression.Automated quantification was significantly less time consuming than automated quantification (17 ? 2 seconds vs 280 ? 78 seconds; P

IntroductionIn acute ischemic stroke, imaging of the cranio-cervical vessels is essential for intra-arterial treatment selection. Fast, reliable and easy accessible imaging is necessary 24 hours a day, 7 days a week. Radiologists in training and non-expert readers often perform initial reviewing. In this pilot study, the potential benefit of adding 4Dimensional-CT Angiography (4D-CTA) to the patient selection protocol for intra-arterial therapy is investigated.Materials and methodsTwenty-five datasets of prospectively recruited patients, eligible for intra-arterial treatment, were enrolled. Four radiologists-in-training consecutively reviewed CTA, CT-Perfusion and 4D-CTA (post-processed from CTP datasets) and scored: occlusion-presence and diagnostic certainty (scale 1-10). Time-to-diagnosis was registered.ResultsArterial occlusion was present in 8 patients. Accuracy improved from 88-92% after CTA and CTP assessment to 96-100% after 4D-CTA assessment (P-values >0,05). Mean diagnostic certainty improved from 7,2-8,6 to 8,8-9,3 (P-values all Conclusion4D-CTA as an additive to regular CTA and CT-Perfusion in patients with acute ischemic stroke eligible for intra-arterial treatment shows a tendency to increase diagnostic accuracy and improves diagnostic certainty, when reviewed by radiologist in training, while only mildly prolonging time to diagnosis.

Background— Medical treatment of initially uncomplicated acute Stanford type-B aortic dissection is associated with a high rate of late adverse events. Identification of individuals who potentially benefit from preventive endografting is highly desirable. Methods and Results— The association of computed tomography imaging features with late adverse events was retrospectively assessed in 83 patients with acute uncomplicated Stanford type-B aortic dissection, followed over a median of 850 (interquartile range 247–1824) days. Adverse events were defined as fatal or nonfatal aortic rupture, rapid aortic growth (>10 mm/y), aneurysm formation (≥6 cm), organ or limb ischemia, or new uncontrollable hypertension or pain. Five significant predictors were identified using multivariable Cox regression analysis: connective tissue disease (hazard ratio [HR] 2.94, 95% confidence interval [CI]: 1.29–6.72; P =0.01), circumferential extent of false lumen in angular degrees (HR 1.03 per degree, 95% CI: 1.01–1.04, P =0.003), maximum aortic diameter (HR 1.10 per mm, 95% CI: 1.02–1.18, P =0.015), false lumen outflow (HR 0.999 per mL/min, 95% CI: 0.998–1.000; P =0.055), and number of intercostal arteries (HR 0.89 per n, 95% CI: 0.80–0.98; P =0.024). A prediction model was constructed to calculate patient specific risk at 1, 2, and 5 years and to stratify patients into high-, intermediate-, and low-risk groups. The model was internally validated by bootstrapping and showed good discriminatory ability with an optimism-corrected C statistic of 70.1%. Conclusions— Computed tomography imaging-based morphological features combined into a prediction model may be able to identify patients at high risk for late adverse events after an initially uncomplicated type-B aortic dissection.

BACKGROUND: Unrealistic expectations about illness duration are likely to result in reconsultations and associated unnecessary antibiotic prescriptions. An evidence-based account of clinical outcomes in patients with lower respiratory tract infection (LRTI) may help avoid unnecessary antibiotic prescriptions and reconsultations. OBJECTIVES: We aimed to identify clinical factors that may predict a prolonged clinical course or poor outcome for patients with LRTI and to provide an evidence-based account of duration of an LRTI and the impact of the illness on daily activities in patients consulting in general practice. METHODS: A prospective cohort study of 247 adult patients with a clinical diagnosis of LRTI presenting to 25 GPs in The Netherlands was carried out. Multivariable Cox regression analysis was used to identify baseline clinical and infection parameters that predicted the time taken for symptoms to resolve. A Kaplan-Meier curve was used to analyse time-to-symptom resolution. Clinical cure was recorded by the GPs at 28 days after the initial consultation and by the patients at 27 days. RESULTS: Co-morbidity of asthma was a statistically significant predictor of delayed symptom resolution, whereas the presence of fever, perspiring and the prescription of an antibiotic weakly predicted enhanced symptom resolution. The GPs considered 89% of the patients clinically cured at 28 days, but 43% of these nevertheless reported ongoing symptoms. Patient-reported cure was much lower (51%), and usual daily activities were limited in 73% of the patients at baseline, and 19% at final follow-up. CONCLUSIONS: The course of LRTI was generally uncomplicated, but the morbidity of this illness was considerable with a longer duration than generally reported, especially for patients with co-existent asthma. These results underline once again the importance of providing GPs with an evidence-based account of outcomes to share with patients in order to set realistic expectations and of enhancing their communication skills within the consultation.

Purpose This study aims to explore the influence of chemoradiation treatment (CRT) on rectal cancer nodes and to generate hypotheses why nodal restaging post-CRT is more accurate than at primary staging. Methods Thirty-nine patients with locally advanced rectal cancer underwent MRI pre- and post-CRT. All visible mesorectal nodes were measured on a 3D T1-weighted gradient echo (3D T1W GRE) sequence with 1-mm3 voxels and matched between pre- and post-CRT-MRI and with histology by lesion-by-lesion matching. Change in number and size of nodes was compared between pre- and post-CRT-MRI. ROC curves were constructed to assess diagnostic performance of size. Results Eight hundred ninety-five nodes were found pre-CRT: 44 % disappeared and 40 % became smaller post-CRT. Disappearing nodes were initially significantly smaller than nodes that remained visible post-CRT: 2.9 mm vs. 3.8 mm. cN+ stage was predicted in 97 % pre-CRT and 36 % of patients had ypN+ post-CRT. ypN+ patients had significantly larger nodes than ypN0 patients both pre- and post-CRT. Optimal size cutoff for post-CRT ypN stage prediction was 2.5 mm (area under the curve (AUC) of 0.78) at MRI. Conclusions After CRT, most lymph nodes become smaller, and many disappear. Size predicts disappearance and node positivity. Together with a low prevalence of ypN+, this can explain the higher accuracy of nodal staging after CRT than in a primary staging setting, possibly of use when considering organ-preserving strategies after CRT.

Aims To compare the prognostic value of negative non-invasive cardiac investigations (coronary computed tomographic angiography [CCTA], cardiovascular magnetic resonance [CMR], exercise electrocardiographic testing [EET], positron emission tomography [PET], stress-echocardiography [SE], and single-photon emission tomography [SPECT]) in patients with suspected or known coronary artery disease (CAD) and to explore the effect of adjustment for population event risk and presence of CAD.Methods and results MEDLINE/PubMed database, EMBASE and Cochrane Library were searched from January-1990 to April-2015 for studies reporting annual event rates (AER) of myocardial infarction (MI) and cardiac death. Pooled estimates of AERs were calculated using a DerSimonian and Laird random-effects model. Multivariable linear meta-regression analysis was performed to compare the AER after a negative test result between modalities and to adjust for population event risk and proportion of patients with CAD. In 165 studies (122,721 patients), pooled AERs after negative test results differed significantly between modalities ranging from 0.32% for CCTA to 1.66% for SE, P Conclusion This meta-analysis is the first study comparing the prognostic value of all available non-invasive cardiac investigations. Outcome differences between modalities after a negative test result are profoundly influenced by large variations in population event risk and a negative test result for all modalities conveys an excellent prognosis for patients with suspected or known CAD.

The aim was to evaluate whether morphological criteria in addition to the size criterion results in better diagnostic performance of MRI for the detection of cervical lymph node metastases in patients with head and neck squamous cell carcinoma (HNSCC). Two radiologists evaluated 44 consecutive patients in which lymph node characteristics were assessed with histopathological correlation as gold standard. Assessed criteria were the short axial diameter and morphological criteria such as border irregularity and homogeneity of signal intensity on T2-weighted and contrast-enhanced T1-weighted images. Multivariate logistic regression analysis was performed: diagnostic odds ratios (DOR) with 95% confidence intervals (95% CI) and areas under the curve (AUCs) of receiver-operating characteristic (ROC) curves were determined. Border irregularity and heterogeneity of signal intensity on T2-weighted images showed significantly increased DORs. AUCs increased from 0.67 (95% CI: 0.61–0.73) using size only to 0.81 (95% CI: 0.75–0.87) using all four criteria for observer 1 and from 0.68 (95% CI: 0.62–0.74) to 0.96 (95% CI: 0.94–0.98) for observer 2 (p

Het doel van deze literatuurstudie is om de effectiviteit na te gaan van intensieve huisbezoekenprogramma's aan ouderen met gezondheidsproblemen of functionele beperkingen. Het doorzoeken van de literatuur was gebaseerd op de ingesloten experimenten van vier literatuurstudies over de effectiviteit van huisbezoeken, gepubliceerd vanaf 2000, en de databestanden van Cinahl, Cochrane, Embase, Medline en PsycINFO vanaf 2001. De zoekstrategie identificeerde 844 studies, waarvan acht voldeden aan de inclusiecriteria. Zeven experimenten waren van voldoende methodologische kwaliteit; geen van deze experimenten hadden, op basis van de belangrijkste analyses, een significant gunstig effect voor de interventiegroep in vergelijking met de controlegroep op mortaliteit, gezondheid, zorggebruik of kosten. De inclusie van minder intensieve programma's voor kwetsbare ouderen zou weinig invloed uitgeoefend hebben op de conclusies van onze literatuurstudie. We concluderen dat huisbezoekenprogramma's niet zinvol lijken voor oudere personen met (ervaren) gezondheidsproblemen binnen het gezondheidszorgsysteem van westerse landen.

Summary Background Erysipelas is a common skin infection that is usually caused by β-haemolytic group A streptococci. After having had erysipelas in an extremity, a significant percentage of patients develops persistent swelling or suffers from recurrent erysipelas. We hypothesize that in cases of erysipelas without a clear precipitating agent, subclinical pre-existing congenital or acquired disturbances in the function of the lymphatic system are present. The persistent swelling after erysipelas is then most likely caused by lymphoedema. Objectives We designed a study to examine if erysipelas of unknown origin is associated with a pre-existent insufficiency of the lymphatic system. If our hypothesis is correct, patients with erysipelas of unkown cause without previously evident lymphoedema should have evidence of disturbed lymphatic transport in the unaffected extremity. Methods A prospective study, in which lymphoscintigraphy of both legs was performed in patients 4 months after presenting with an episode of erysipelas only in one leg. No patient had any known risk factor for erysipelas, such as diabetes mellitus, chronic venous insufficiency or clinical signs of lymphoedema. Lymphoscintigraphy was performed in 40 patients by subcutaneous injection of Tc-99m-labelled human serum albumin in the first web space of both feet. After 30 and 120 min, quantitative and qualitative scans were performed using a computerized gamma camera. During the lymphoscintigraphy, the patients performed a standardized exercise programme. Lymph drainage was quantified as the percentage uptake of Tc-99m-labelled human serum albumin in the groin nodes at 2 h after injection. Groin uptake of 20% as normal. Results The mean ± SD percentage uptake in the groin nodes in the affected limbs was 9·6 ± 8·5% vs. 12·1% ± 8·9% in the nonaffected limbs. The mean paired difference in uptake between the nonaffected vs. affected side was 2·5% (95% confidence interval 1·1–3·9%). This indicates that lymphatic drainage in the nonaffected limb was only slightly better than in the affected limb despite the infectious event in the latter. Of 33 patients with objective impairment of lymph drainage in the affected limb, 26 (79%) also had impaired lymph drainage in the nonaffected limb. Agreement in qualitative measurements between affected and nonaffected leg was less pronounced: 21 patients had abnormal qualitative results in the affected leg of whom nine also had impairment of the nonaffected leg (43%). Conclusions Erysipelas is often presumed to be purely infectious in origin, with a high rate of recurrence and a risk of persistent swelling due to secondary lymphoedema. In this study, we show that patients presenting with a first episode of erysipelas often have signs of pre-existing lymphatic impairment in the other, clinically nonaffected, leg. This means that subclinical lymphatic dysfunction of both legs may be an important predisposing factor. Therefore, we recommend that treatment of erysipelas should focus not only on the infection but also on the lymphological aspects, and long-standing treatment for lymphoedema is essential in order to prevent recurrence of erysipelas and aggravation of the pre-existing lymphatic impairment. Our study may change the clinical and therapeutic approach to erysipelas as well as our understanding of its aetiology.

Background Unstable plaque characteristics on coronary CT angiography (CTA), serum high-sensitivity cardiac troponin T (hs-cTnT) and N-terminal Pro-Brain Natriuretic Peptide (NT-proBNP) concentrations are associated with cardiovascular events. Objective To investigate the association between coronary CTA defined quantifiable plaque characteristics, hs-cTnT and NT-proBNP. Methods 81 consecutive stable chest pain patients with an intermediate-to-high risk were analyzed. Coronary CTA was performed using a 64-slice multidetector-row CT-scanner. Total coronary plaque volume, calcified volume, non-calcified volume, plaque burden, remodeling index (RI) and number of plaques were measured using dedicated software. A total plaque score ("Sum plaque score") incorporating total plaque volume, RI, plaque burden and number of plaques was defined. Hs-cTnT and NT-proBNP concentrations were measured in serum samples before coronary CTA. Results Univariate regression analysis demonstrated significant associations of hs-cTnT and NT-proBNP with total plaque volume ( r hs-cTnT = .256; r NT-proBNP = .270), calcified volume ( r hs-cTnT = .344; r NT-proBNP = .344), RI ( r hs-cTnT = .335; r NT-proBNP = .342) and number of plaques ( r hs-cTnT = .355; r NT-proBNP = .301) (all P values ≤ .021). Non-calcified plaque volume showed no association with hs-cTnT and NT-proBNP ( r hs-cTnT = .050; r NT-proBNP = .087; P value = .660 and P value = .442). The "Sum plaque score" showed the highest correlation compared to other plaque parameters ( r hs-cTnT = .362; r NT-proBNP = .409; P value = .001 and P value ≤ .001). Conclusion Our data suggest that coronary plaque morphology parameters, derived by dedicated software, are associated with serum hs-cTnT and NT-proBNP concentrations.

Purpose To perform a meta-analysis comparing ultrasonography (US), US guided fine needle aspiration cytology (USgFNAC), computed tomography (CT), and magnetic resonance imaging (MRI) in the detection of lymph node metastases in head and neck cancer. Methods MEDLINE, EMBASE and Cochrane databases were searched (January 1990–January 2006) for studies reporting diagnostic performances of US, USgFNAC, CT, and MRI to detect cervical lymph node metastases. Two reviewers screened text and reference lists of potentially eligible articles. Criteria for study inclusion: (1) histopathology was the reference standard, (2) primary tumors and metastases were squamous cell carcinoma and (3) data were available to construct 2 × 2 contingency tables. Meta-analysis of pairs of sensitivity and specificity was performed using bivariate analysis. Summary estimates for diagnostic performance used were sensitivity, specificity, diagnostic odds ratios (DOR) (95% confidence intervals) and summary receiver operating characteristics (SROC) curves. Results From seventeen articles, 25 data sets could be retrieved. Eleven articles studied one modality: US (n = 4); USgFNAC (n = 1); CT (n = 3); MRI (n = 3). Six articles studied two or more modalities: US and CT (n = 2); USgFNAC and CT (n = 1); CT and MRI (n = 1); MRI and MRI-USPIO (Sinerem®) (n = 2); US, USgFNAC, CT and MRI (n = 1). USgFNAC (AUC = 0.98) and US (AUC = 0.95) showed the highest areas under the curve (AUC). MRI-USPIO (AUC = 0.89) and CT (AUC = 0.88) had similar results. MRI showed an AUC = 0.79. USgFNAC showed the highest DOR (DOR = 260) compared to US (DOR = 40), MRI-USPIO (DOR = 21), CT (DOR = 14) and MRI (DOR = 7). Conclusion USgFNAC showed to be the most accurate imaging modality to detect cervical lymph node metastases.

To use a decision analytic model to determine the cost-effectiveness of performing diagnostic digital subtraction angiography (DSA), computed tomographic (CT) angiography, or magnetic resonance (MR) angiography or proceeding immediately to tentative percutaneous revascularization in patients suspected of having renovascular hypertension.With use of a Markov-Monte Carlo decision model, cost-effectiveness analysis was performed from a societal perspective. Data were derived from the Renal Artery Diagnostic Imaging Study in Hypertension and from published literature. The base-case analyses were used to evaluate a 50-year-old patient with a diastolic blood pressure higher than 95 mm Hg and one or more clinical clues suggestive of renovascular hypertension. Outcome measures were quality-adjusted life-year (QALY), lifetime costs, and incremental cost-effectiveness.For a 50-year-old male patient, immediate tentative revascularization was the least costly (euro54 415) and most effective (12.265 QALYs) strategy. For the other strategies, costs and QALYs, respectively, were euro55 570 and 12.195 for DSA, euro55 191 and 12.163 for CT angiography, and euro56 890 and 12.088 for MR angiography. For a 50-year-old female patient, costs and QALYs, respectively, were euro66 731 and 13.731 for MR angiography, euro63 970 and 13.749 for CT angiography, and euro63 079 and 13.902 for DSA. Immediate tentative revascularization yielded more QALYs (13.937) and was more costly (euro63 329) than DSA. The incremental cost-effectiveness ratio was euro7143 per QALY. As the prior probability increased, use of a more invasive diagnostic imaging strategy became justified. Also, the sensitivities of CT angiography and MR angiography and the costs of DSA influenced the results.Given currently accepted incremental cost-effectiveness ratios, immediate tentative percutaneous revascularization is a cost-effective strategy for the diagnosis of renal artery stenosis. Management decisions should be conditional on the prior probability.

It is still uncertain whether one can safely base treatment decisions on self-measurement of blood pressure. In the present study, we investigated whether antihypertensive treatment based on self-measurement of blood pressure leads to the use of less medication without the loss of blood pressure control. We randomly assigned 430 hypertensive patients to receive treatment either on the basis of self-measured pressures (n=216) or office pressures (OPs; n=214). During 1-year follow-up, blood pressure was measured by office measurement (10 visits), ambulatory monitoring (start and end), and self-measurement (8 times, self-pressure group only). In addition, drug use, associated costs, and degree of target organ damage (echocardiography and microalbuminuria) were assessed. The self-pressure group used less medication than the OP group (1.47 versus 2.48 drug steps; P P P =0.25/0.20), in changes in left ventricular mass index (−6.5 g/m 2 versus −5.6 g/m 2 ; P =0.72), or in median urinary microalbumin concentration (−1.7 versus −1.5 mg per 24 hours; P =0.87). Nevertheless, 24-hour ambulatory blood pressure values at the end of the trial were higher in the self-pressure than in the OP group: 125.9 versus 123.8 mm Hg ( P P

Non-adherence to antihypertensive drugs is high, and the economic consequences of non-adherence may be substantial. The Medication Events Monitoring System (MEMS), which is a method to improve adherence, has been shown to be a useful tool for the management of adherence problems.To assess the cost effectiveness of the MEMS compared with usual care in a population of hypertensive patients with poor adherence. The MEMS programme consisted of provision of containers fitted with electronic caps together with adherence training if indicated.In a randomised controlled trial, 164 hypertensive patients in the experimental strategy and 89 patients in the usual care strategy were followed for 5 months. Patients who had a systolic blood pressure (SBP)or = 160 mm Hg and/or diastolic BP (DBP)or = 95 mm Hg despite the use of antihypertensive drugs were eligible. Patients were recruited by a GP, and treatment took place in general practice. In the experimental strategy, electronic monitoring of the intake of antihypertensive drugs was introduced without change of medication. Unsatisfactory adherence was defined as85% of days with the number of doses taken as prescribed. In the usual care strategy, antihypertensive treatment was intensified by the addition or change of antihypertensive drugs, if necessary, without provision of an electronic monitor. Outcome parameters included the proportion of patients with normalised blood pressure (NBP) at 5 months and QALYs. Costs were quantified from the healthcare and societal perspective. Non-parametric bootstrap simulations were performed to quantify the uncertainty around the mean estimates and cost-effectiveness acceptability curves were presented. In addition, a number of univariate sensitivity analyses were performed on deterministic variables.At 5 months, 3.1% (95% UI [uncertainty interval] -9.7%, +15.8%) more patients had NBP, and 0.003 (95% UI -0.005, +0.010) more QALYs were generated in the experimental strategy. A statistically significant lower percentage of patients had a dose escalation in the experimental strategy. Irrespective of the ceiling ratio for cost effectiveness, the cost-effectiveness probability was between 75% and 80% for the analysis from the healthcare perspective using proportion of patients with NBP as the outcome parameter. For the analysis from the societal perspective using QALYs as the outcome parameter, this probability was between 45% and 51%.For a time horizon of 5 months, a difference in both cost and effect could not be detected between an adherence-improving programme compared with usual care for hypertensive patients. The probability that the adherence-improving programme is cost effective is at best moderate. Moreover, the cost-effectiveness result is surrounded with considerable uncertainty and large-scale implementation warrants additional research into the economic consequences of this intervention. Patients may benefit from the use of a MEMS monitor in situations where BP targets are not reached because of suspected non-adherence and both patient and GP are reluctant to increase the dose or number of antihypertensive drugs.

Background: Nonsteroidal anti-inflammatory drugs and vitamin-D derivatives can target signaling pathways activated in basal cell carcinoma (BCC). Objective: We investigated the efficacy of topically applied diclofenac sodium 3% gel, calcitriol 3 mu g/g ointment, and a combination of both in superficial BCC (sBCC) and nodular BCC. Methods: Patients with a primary, histologically proven sBCC (n = 64) or nodular BCC (n = 64) were randomized to topical diclofenac, calcitriol, combination of both, or no topical treatment (control group). After self-application twice daily under occlusion (8 weeks), tumors were excised. Primary outcome was posttreatment expression levels of proliferation (Ki-67) and antiapoptosis (B-cell lymphoma [Bcl-2]) immunohistochemical markers. Secondary outcomes were histologic clearance, adverse events, application-site reactions, and patient compliance. Results: sBCC treated with diclofenac showed a significant decrease in Ki-67 (P

Objectives To analyse predictors for short- and long-term renal function changes after fenestrated and branched endovascular aortic repair (EVAR). Methods A total of 157 patients underwent fenestrated and branched EVAR. Procedural intra-arterial iodinated contrast volume was documented. Serum creatinine and estimated glomerular filtration rate (eGFR) at baseline, during 48 h following EVAR, at discharge and latest moment of follow-up were recorded. Development of post-EVAR acute kidney injury (AKI; according to AKIN criteria), and potential risk factors for renal failure were recorded. Multivariate regression analyses were used to identify independent risk factors for AKI and eGFR decrease during follow-up. Results Forty-three patients (28 %) developed post-EVAR AKI. Long procedure time and occlusion of accessory renal arteries were independent risk factors for development of AKI. (odds ratio (OR) 1.005 per minute, 95 % CI 1.001–1.01; p = 0.025 and OR 3.02, 95 % CI 1.19–8.16; p = 0.029). Post-EVAR AKI was associated with a significantly increased risk for eGFR decrease at discharge and latest follow-up (hazard ratio (HR) 3.47, 95 % CI 1.63–7.36, p = 0.001 and HR 3.01, 95 % CI 1.56–5.80; p = 0.001). Iodinated contrast volume was not an independent risk factor for AKI or eGFR decrease during follow-up. Conclusion Development of post-EVAR AKI is an independent risk factor for long-term renal function decrease. Key Points • Longer procedure time is associated with an increased risk for AKI. • Renal perfusion defects on angiography are associated with increased risk for AKI. • Post-EVAR AKI is associated with higher probability for long-term eGFR decrease. • Iodinated contrast volume is not an independent risk factor for AKI. • Iodinated contrast volume is not an independent risk factor for long-term eGFR decrease.

Contains fulltext : 49785_pub.pdf (Publisher’s version ) (Closed access) PURPOSE: To prospectively determine the clinical and economic consequences of replacing duplex ultrasonography (US) with contrast material-enhanced magnetic resonance (MR) angiography for the initial imaging work-up of patients with peripheral arterial disease (PAD). MATERIALS AND METHODS: This randomized multicenter study was approved by the institutional review board of each hospital, and all patients signed written informed consent prior to randomization. Patients with PAD who needed to undergo imaging work-up and who had an ankle-brachial pressure index (ABPI) of less than 0.90 were recruited by vascular surgeons between January 2002 and September 2003. Patients were randomly assigned to undergo contrast-enhanced MR angiography or duplex US. The primary outcome measure was cost. Secondary outcome measures included therapeutic confidence, changes in disease severity, and changes in quality of life (QOL) assessed during 6 months of follow-up. Indicators for disease severity were based on the Rutherford classification, treadmill walking distance, ABPI at rest, and ABPI after exercise. QOL was assessed with the Rating Scale, Short Form 36, EuroQol-5D, and VascuQol questionnaires. The cost of (additional) imaging procedures, therapeutic interventions, and outpatient visits were calculated from a hospital perspective (ie, all costs incurred inside the hospital were estimated, including physician costs). Data were evaluated by using the Student t test and a multivariable linear regression analysis. RESULTS: At 6 months, 352 patients (239 [68%] men, 113 [32%] women; mean age, 65 years) were analyzed. The use of contrast-enhanced MR angiography versus duplex US reduced the number of additional vascular imaging procedures by 42%; contrast-enhanced MR angiography was also associated with higher therapeutic confidence. Diagnostic costs for contrast-enhanced MR angiography were 167 euros (186 dollars) higher than those for duplex US (P < .001). No statistically significant differences were found for total cost, changes in disease severity, or changes in QOL between patients examined with duplex US and those examined with contrast-enhanced MR angiography (P > .05). CONCLUSION: Replacing duplex US with contrast-enhanced MR angiography for the initial imaging work-up of patients with PAD reduces the need for additional imaging, although diagnostic costs are higher.

To determine the costs associated with the diagnostic work-up and percutaneous revascularization of renal artery stenosis from various perspectives. A prospective multicenter comparative study was conducted between 1998 and 2001. A total of 402 hypertensive patients with suspected renal artery stenosis were included. Costs were assessed of computed tomography angiography (CTA), magnetic resonance angiography (MRA), digital subtraction angiography (DSA), and percutaneous revascularization. From the societal perspective, DSA was the most costly (euro 1,721) and CTA the least costly diagnostic technique (euro 424). CTA was the least costly imaging procedure irrespective of the perspective used. The societal costs associated with percutaneous renal artery revascularization ranged from euro 2,680 to euro 6,172. Overall the radiology department incurred the largest proportion of the total societal costs. For the management of renal artery stenosis, performing the analysis from different perspectives leads to the same conclusion concerning the least costly diagnostic imaging and revascularization procedure.

Contains fulltext : 48963.pdf (Publisher’s version ) (Closed access) BACKGROUND: Several methods of randomization are available to create comparable intervention groups in a study. In the HOMERUS-trial, we compared the minimization procedure with a stratified and a non-stratified method of randomization in order to test which one is most appropriate for use in clinical hypertension trials. A second objective of this article was to describe the baseline characteristics of the HOMERUS-trial. METHODS: The HOMERUS population consisted of 459 mild-to-moderate hypertensive subjects (54% males) with a mean age of 55 years. These patients were prospectively randomized with the minimization method to either the office pressure (OP) group, where antihypertensive treatment was based on office blood pressure (BP) values, or to the self-pressure (SP) group, where treatment was based on self-measured BP values. Minimization was compared with two other randomization methods, which were performed post-hoc: (i) non-stratified randomization with four permuted blocks, and (ii) stratified randomization with four permuted blocks and 16 strata. In addition, several factors that could influence outcome were investigated for their effect on BP by 24-h ambulatory blood pressure monitoring (ABPM). RESULTS: Minimization and stratified randomization did not lead to significant differences in 24-h ABPM values between the two treatment groups. Non-stratified randomization resulted in a significant difference in 24-h diastolic ABPM between the groups. Factors that caused significant differences in 24-h ABPM values were: region, centre of patient recruitment, age, gender, microalbuminuria, left ventricular hypertrophy and obesity. CONCLUSION: Minimization and stratified randomization are appropriate methods for use in clinical trials. Many outcome factors should be taken into account for their potential influence on BP levels. Recommendation. Due to the large number of potential outcome factors that can influence BP levels, minimization should be the preferred method for use in clinical hypertension trials, as it has the potential to randomize more outcome factors than stratified randomization.

Renal artery stenosis (RAS) is a potentially curable cause of renovascular hypertension (RVH) and is caused by either atherosclerosis or fibromuscular dysplasia (FMD) in the vast majority of patients. Although intra-arterial digital subtraction angiography (IA-DSA) is still considered the standard of reference test for the anatomical diagnosis of RAS, noninvasive techniques such as MR angiography, CT angiography, and color-aided duplex ultrasonography are promising alternatives that also allow functional characterization of RAS. We provide an overview of these techniques and discuss their relative merits and shortcomings. Analysis of high-quality studies shows that both MR and CT angiography are significantly more accurate for the diagnosis of at least 50% atherosclerotic RAS than ultrasonographic techniques. The primary strength of ultrasonography at present is its suggested ability to predict functional recovery based on preinterventional resistance index measurements. A still unresolved issue is the detection of FMD. Because missing RVH may have serious consequences the most important requirement for a screening test is that it has high sensitivity.

To prospectively compare the diagnostic accuracies of color duplex ultrasonography (US) and contrast material-enhanced magnetic resonance (MR) angiography and to assess interobserver agreement regarding contrast-enhanced MR angiographic findings in patients suspected of having peripheral arterial disease (PAD).The institutional review board approved the study, and all patients provided signed informed consent. Two hundred ninety-five patients referred for diagnostic and preinterventional work-up of PAD with duplex US also underwent gadolinium-enhanced MR angiography. Data sets were reviewed for presence or absence of 50% or greater luminal reduction, which indicated hemodynamically significant stenosis, and to determine interobserver agreement. At duplex US, a peak systolic velocity ratio of 2.5 or greater indicated significant stenosis. Primary outcome measures were differences between duplex US and contrast-enhanced MR angiography in sensitivity and specificity for detection of significant stenosis, as assessed with the McNemar test, and interobserver agreement between the two contrast-enhanced MR angiogram readings, expressed as quadratic weighted kappa values. Intraarterial digital subtraction angiography (DSA) was the reference standard.Two hundred forty-nine patients had at least one hemodynamically significant stenotic lesion at contrast-enhanced MR angiography, duplex US, or both examinations. One hundred fifty-two patients underwent intraarterial DSA. The quadratic weighted kappa for agreement regarding the presence of 50% or greater stenosis at contrast-enhanced MR angiography was 0.89 (95% confidence interval [CI]: 0.87, 0.91). Sensitivity of duplex US was 76% (95% CI: 69%, 82%); specificity, 93% (95% CI: 91%, 95%); and accuracy, 89%. Sensitivity and specificity of contrast-enhanced MR angiography were 84% (95% CI: 78%, 89%) and 97% (95% CI: 95%, 98%), respectively; accuracy was 94%. Sensitivity (P = .002) and specificity (P = .03) of contrast-enhanced MR angiography were significantly higher.Results of this prospective comparison between contrast-enhanced MR angiography and duplex US provide evidence that contrast-enhanced MR angiography is more sensitive and specific for diagnosis and preinterventional work-up of PAD.

ObjectiveThis study compared the ability of generic and disease-specific questionnaires to assess quality of life (QOL) at baseline and to detect change in QOL after treatment in patients with peripheral arterial disease (PAD).MethodsThis prospective multicenter trial recruited 514 patients with PAD who needed an imaging workup and had an ankle brachial pressure index of less than 0.90. Patients with severe comorbidity were excluded, leaving a study population of 450 patients. Patients completed two generic questionnaires, the Short Form 36 (SF-36) and the European Quality of Life 5D (EuroQol-5D), and one disease-specific questionnaire, the Vascular Quality of Life (VascuQol) at baseline and after 6 months of follow-up. Rutherford classification and treadmill walking distance were determined at baseline and after 6 months of follow-up and were considered indicators of disease severity. Receiver operating characteristic (ROC) curves and areas under the curves (AUCs) were used to evaluate each of the three questionnaires for its ability to discriminate between severe and mild disease at baseline and to discriminate between a large and small change in disease severity after follow-up. The underlying assumption was that disease severity is a major determinant of QOL. This implies that the validity of a QOL questionnaire is reflected by its ability to discriminate between mildly and severely diseased patients.ResultsAt baseline, 443 patients and after follow-up, 386 patients completed questionnaires. At baseline, no significant (P >.05) differences were observed among AUCs for the total scores of the three questionnaires, indicating that all three questionnaires assessed the disease severity equally well. After follow-up, the AUCs for the VascuQol were significantly higher than the AUCs for the SF-36 and EuroQol-5D with respect to detection of improvement in Rutherford classification (P < .05), indicating that change in disease severity after follow-up was best detected by the VascuQol.ConclusionThe VascuQol is the preferred questionnaire as outcome measure for QOL in future trials and clinical follow-up of patients with PAD.

Item does not contain fulltext The Home versus Office MEasurements, Reduction of Unnecessary treatment Study (HOMERUS) is a multicentre prospective study, primarily designed to examine in subjects with mild to moderate hypertension whether treatment decisions based on home blood pressure measurements can lead to reduction in the use of antihypertensive drugs and the associated costs, compared to office blood pressure measurements. After inclusion, 360 patients are randomized to two groups. In one group, antihypertensive therapy is based on blood pressure measured in the outpatient clinic: the office pressure (OP) group. In the other group, antihypertensive therapy is based on home blood pressure measurements: the self-pressure (SP) group. All readings, both in OP and in SP, are obtained with the same validated oscillometric device, the Omron 705 CP. Treatment decisions are taken by an independent physician at the coordinating centre, who is unaware whether the patient belongs to the SP or OP group. Following a standardized treatment schedule, blood pressure is targeted at 120-139 mmHg for systolic and 80-89 mmHg for diastolic pressure. Patients are followed for 1 year. At the start and at the end of the study, ambulatory blood pressure measurements are obtained as a reference. Microalbuminuria and echocardiography are assessed to evaluate the possible development of target organ damage. It is expected that, at the end of the trial, patients in both groups will have the same blood pressure, at the expense of more medication in the OP group. Therefore, a cost-minimization analysis will be performed first. If short-term effects appear not to be comparable for OP and SP, a cost-effectiveness analysis will be performed to assess the value of the SP strategy in comparison to standard practice. In addition, medication compliance is recorded within random subgroups of the SP and OP groups by means of Medication Event Monitoring System (MEMS) V TrackCaps.

Hopstaken RM, Nelemans P, Stobberingh EE, Muris JWM, Rinkens PELM, Dinant GJ. Behandeling van acute lage-luchtweginfecties in de huisartsenpraktijk. Een dubbelblind, gerandomiseerd onderzoek met amoxicilline versus roxitromycine. Huisarts Wet 2003;46(2):73-9. Doelstelling Het beoordelen van de werkzaamheid van roxitromycine versus amoxicilline. Methode In een dubbelblind gerandomiseerd onderzoek is de werkzaamheid van driemaal daags oraal 500 mg amoxicilline vergeleken met die van eenmaal daags oraal 300 mg roxitromycine gedurende 10 dagen. Honderdzesennegentig volwassenen bij wie de huisarts een lage-luchtweginfectie (LLWI) constateerde, en die naar het oordeel van de arts met een antibioticum dienden te worden behandeld, werden geincludeerd. Uitkomstmaten De klinische genezing werd na 10 (primaire uitkomstmaat) en 28 dagen gemeten, waarbij de respons als volgt werd gedefinieerd: afname van LLWI-klachten; volledig ontbreken van LLWI-klachten; afname van afwijkende bevindingen bij lichamelijk onderzoek en volledig ontbreken van afwijkende bevindingen bij lichamelijk onderzoek. De eindconclusie van de huisarts (genezing ja/nee), bacteriologische genezing, het bijwerkingenprofiel en de therapietrouw werden bepaald. Daarnaast werd de tijd vastgesteld tot de klachten verminderden en verdwenen en de tijd tot hervatting van dagelijkse bezigheden, die geheel of gedeeltelijk achterwege waren gebleven op de dagen 1 tot en met 10, 21 en 27. Resultaten De klinische genezingspercentages na voltooiing van de antibioticumkuur (10 dagen) waren voor de 2 groepen niet significant verschillend. Na 28 dagen bleek in de roxitromycinegroep aan de hand van afname van klachten het genezingspercentage niet te zijn toegenomen. Dit significante verschil veranderde echter niets aan de eindconclusie van de huisartsen na afronding van de follow-up: 90% van de patienten was, ongeacht de leeftijd, effectief behandeld met ofwel amoxicilline ofwel roxitromycine. Conclusies De toegevoegde waarde van roxitromycine werd niet bevestigd. Amoxicilline blijft een betrouwbaar antibioticum van eerste keus bij de behandeling van LLWI in de huisartsenpraktijk.

Purpose: To assess and quantify the magnitude and direction of respiratory movement of the aorta and origins of its side branches. Methods: A quantitative 3-dimensional (3D) subtraction analysis of computed tomography (CT) scans during inspiration and expiration was performed to determine the respiratory geometric movements of the aorta and side branches in 60 patients. During breath-hold expiration and inspiration, 1-mm-thick CT slices of the aorta were acquired in unenhanced and contrast-enhanced scans. The datasets were compared using dedicated multiplanar reformation image subtraction software to determine the change in position of relevant anatomic sections, including the ascending thoracic aorta (AA), the origins of the brachiocephalic artery (BA) and left subclavian artery (LSA), the descending thoracic aorta (DTA) at the level of the tenth thoracic vertebra, as well as the origins of the celiac trunk, superior mesenteric artery, and the renal arteries. Results: Complex movement was visible during inspiration; the regions of interest in the thoracic aorta and side branches moved in the anterior, medial, and caudal directions compared with the expiration state. Mean 3D movement vectors (± standard deviation) were 8.9±3.6 mm (AA), 12.0±4.1 mm (BA), 11.1±3.9 mm (LSA), and 4.9±2.5 mm (DTA). Abdominal side branches moved in the caudal direction 1.3±1.1 mm. There was significantly less movement in the DTA compared to AA (p