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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 d

Item does not contain fulltext, PURPOSE: To assess the predictive value of a short magnetic resonance (MR) imaging examination, in addition to or instead of radiography, performed in patients with acute knee trauma to identify those who require additional treatment versus those who do not and can be discharged without further follow-up. MATERIALS AND METHODS: The randomized controlled trial and use of collected data for prediction modeling were approved by the institutional review board; informed consent was obtained. Patients with recent knee injury were included in the trial if radiography was ordered. They were randomized into a group undergoing only radiography and a group undergoing radiography plus immediate MR imaging. A 0.2-T dedicated extremity MR imager and four short pulse sequences were used. Univariable and multivariable logistic regression analysis was used to evaluate patient characteristics, trauma mechanism, and findings at radiography and MR imaging for their value in prediction of need for subsequent treatment within the 6-month follow-up. RESULTS: Data in 189 patients (123 male patients, 66 female patients; mean age, 33.4 years), 109 of whom underwent treatment after their initial visit, were analyzed. Age of 30 years or older, indirect trauma mechanism, radiographic results, and MR imaging results were significant predictors of need for treatment in univariable and multivariable analyses (P < .05). In the multivariable analysis, only abnormal MR imaging results were significantly predictive of need for treatment, and only when MR imaging replaced radiography (odds ratio, 2.61; 95% confidence interval: 1.12, 6.06). CONCLUSION: Implementation of a dedicated extremity MR imaging examination, in addition to or instead of radiography, performed in patients with traumatic knee injury improves prediction of the need for additional treatment but does not significantly aid in identification of patients who can be discharged without further follow-up. Value of a short MR imaging examina

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Item does not contain fulltext, PURPOSE: To assess prospectively if a short imaging examination performed with low-field-strength dedicated magnetic resonance (MR) imaging in addition to radiography is effective and cost saving compared with the current diagnostic imaging strategy (radiography alone) in patients with recent acute traumatic injury of the wrist, knee, or ankle. MATERIALS AND METHODS: Institutional review board approval and informed consent were obtained. Patients with recent trauma of the wrist, knee, or ankle were randomized across two diagnostic strategies: radiography alone (reference group) or radiography followed by a short MR imaging examination (intervention group). Measures of effectiveness included the number of additional diagnostic procedures, time to last diagnostic procedure, and number of days absent from work. Measures of effectiveness were analyzed by using an exact Wilcoxon-Mann-Whitney test. Time to convalescence and quality of life were analyzed by using a t test. Cost analysis was performed from a societal perspective and analyzed by using a t test. RESULTS: Five hundred patients (207 women, 293 men; mean age, 34.8 years) with acute injury of the wrist, knee, or ankle were randomized. In the intervention group, quality of life for patients with knee injuries was significantly higher during the first 6 weeks, and time to completion of diagnostic work-up was significantly shorter (mean, 3.5 days for intervention group vs 17.3 days for reference group). The number of additional diagnostic procedures was significantly lower in the intervention group versus the reference group (nine vs 35, respectively) for patients with knee injuries. Patients with knee injuries showed the largest difference in costs (intervention group, 1820 [$1966]; reference group, 2231 [$2409]) owing to a reduction in productivity loss. Costs were higher in patients with wrist injuries and almost equal in patients with ankle injuries. All cost differences, however, were not significant. CONCLUSIO

Contains fulltext : 48470.pdf (publisher's version ) (Closed access), CONTEXT: Two decision rules for indications of computed tomography (CT) in patients with minor head injury, the Canadian CT Head Rule (CCHR) and the New Orleans Criteria (NOC), suggest that CT scanning may be restricted to patients with certain risk factors, which would lead to important reductions in the use of CT scans. OBJECTIVE: To validate and compare these 2 published decision rules in Dutch patients with head injuries. DESIGN, SETTING, AND PATIENTS: A prospective multicenter study conducted between February 11, 2002, and August 31, 2004, in 4 university hospitals in the Netherlands of 3181 consecutive adult patients with minor head injury who presented with a Glasgow Coma Scale (GCS) score of 13 to 14 or with a GCS score of 15 and at least 1 risk factor. MAIN OUTCOME MEASURES: Primary outcome was any neurocranial traumatic finding on CT scan. Secondary outcomes were neurosurgical intervention and clinically important CT findings. Sensitivity and specificity were estimated for each outcome for the CCHR and the NOC, using both rules as originally derived and also as adapted to apply to an expanded patient population. RESULTS: Of 3181 patients with a GCS score of 13 to 15, neurosurgical intervention was performed in 17 patients (0.5%); neurocranial traumatic CT findings were present in 312 patients (9.8%). Sensitivity for neurosurgical intervention was 100% for both the CCHR and the NOC. The NOC had a higher sensitivity for neurocranial traumatic findings and for clinically important findings (97.7%-99.4%) than did the CCHR (83.4%-87.2%). Specificities were very low for the NOC (3.0%-5.6%) and higher for the CCHR (37.2%-39.7%). The estimated potential reduction in CT scans for patients with minor head injury would be 3.0% for the adapted NOC and 37.3% for the adapted CCHR. CONCLUSIONS: For patients with minor head injury and a GCS score of 13 to 15, the CCHR has a lower sensitivity than the NOC for neurocranial traumatic or clinically important CT findings, but

Item does not contain fulltext, PURPOSE: To assess predictive value of a short magnetic resonance (MR) imaging examination in addition to or instead of radiography in patients with acute wrist trauma to identify patients who require additional treatment versus those who do not and can be discharged without further follow-up. MATERIALS AND METHODS: Informed consent was obtained from all participating patients; the institutional review board approved the randomized controlled trial and use of data to create prediction models. Of 90 patients (37 female, 53 male; mean age, 40.0 years), 87 with acute wrist trauma were randomized to undergo radiography (n = 43) or radiography and a short MR imaging examination with low-field-strength dedicated extremity MR system (n = 44). Age, sex, trauma mechanism, presence of tenderness of the anatomic snuffbox, radiographic results, MR imaging results, and treatment data were collected. Univariable and multivariable logistic regression analysis was used to create four models for prediction of treatment need. RESULTS: Thirty-six patients had one or more fractures; one patient had a marked soft-tissue lesion. In univariable analysis, age (odds ratio, 1.02; 95% confidence interval: 1.00, 1.05), anatomic snuffbox tenderness (odds ratio, 2.31; 95% confidence interval: 0.90, 5.96), radiographic results (odds ratio, 31.2; 95% confidence interval: 8.90, 109), and positive MR imaging results versus MR imaging not performed (odds ratio, 1.86; 95% confidence interval: 0.57, 6.06) were significantly predictive of treatment need. In multivariable analysis, radiographic results (odds ratio, 24.7; 95% confidence interval: 6.59, 93.1) and positive MR imaging results (odds ratio, 6.28; 95% confidence interval: 1.27, 31.0) were significantly predictive of treatment need. Negative MR imaging results were not significantly predictive (odds ratio, 0.87; 95% confidence interval: 0.20, 3.82). CONCLUSION: A short MR imaging examination with a low-field-strength MR imaging system following

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At many institutions, magnetic resonance (MR) angiography is the technique of choice for assessment of the renal arteries and renal parenchyma in potential living kidney donors. The renal arteries and renal veins have a varied anatomy and may consist of one or more vessels at several levels with variable calibers and levels of branching. These findings may play an important role in the surgeon's decision about which kidney to harvest, especially if laparoscopic nephrectomy is used. A comprehensive MR imaging protocol is used at one hospital to assess the arteries, veins, parenchyma, and collecting system of the kidneys. The protocol includes T2-weighted single-shot fast spin-echo imaging, fat-saturated T2-weighted fast spin-echo imaging, three-dimensional MR angiography and MR venography, and delayed fat-saturated three-dimensional T1-weighted gradient-echo imaging. Meticulous assessment of the source images as well as images produced with various postprocessing methods, such as full maximum intensity projection, targeted maximum intensity projection, and axial and oblique reformation, allows detailed description of the vascular anatomy and its relationship to the collecting system and parenchyma to facilitate the surgeon's decision making. The findings of MR imaging are comparable with those of other imaging modalities.

PURPOSE: To determine the most cost-effective strategy for preoperative imaging performed in potential living renal donors. MATERIALS AND METHODS: In a decision-analytic model, the societal cost-effectiveness of digital subtraction angiography (DSA), gadolinium-enhanced magnetic resonance (MR) angiography, contrast material-enhanced spiral computed tomographic (CT) angiography, and combinations of these imaging techniques was evaluated. Outcome measures included lifetime cost, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios. A base-case analysis was performed with a 40-year-old female donor and a 40-year-old female recipient. RESULTS: For the donor, MR angiography (24.05 QALYs and 9,000 dollars) dominated all strategies except for MR angiography with CT angiography, which had an incremental ratio of 245,000 dollars per QALY. For the recipient, DSA and DSA with MR angiography yielded similar results (10.46 QALYs and 179,000 dollars) and dominated all other strategies. When results for donor and recipient were combined, DSA dominated all other strategies (34.51 QALYs and 188,000 dollars). If DSA was associated with a 99% specificity or less for detection of renal disease, MR angiography with CT angiography was superior (34.47 QALYs and 190,000 dollars). CONCLUSION: For preoperative imaging in a potential renal donor, DSA is the most cost-effective strategy if it has a specificity greater than 99% for detection of renal disease; otherwise, MR angiography with CT angiography is the most cost-effective strategy.

OBJECTIVE: To evaluate the discriminatory value and compare the predictive performance of six non-invasive tests used for perioperative cardiac risk stratification in patients undergoing major vascular surgery. DESIGN: Meta-analysis of published reports. METHODS: Eight studies on ambulatory electrocardiography, seven on exercise electrocardiography, eight on radionuclide ventriculography, 23 on myocardial perfusion scintigraphy, eight on dobutamine stress echocardiography, and four on dipyridamole stress echocardiography were selected, using a systematic review of published reports on preoperative non-invasive tests from the Medline database (January 1975 and April 2001). Random effects models were used to calculate weighted sensitivity and specificity from the published results. Summary receiver operating characteristic (SROC) curve analysis was used to evaluate and compare the prognostic accuracy of each test. The relative diagnostic odds ratio was used to study the differences in diagnostic performance of the tests. RESULTS: In all, 8119 patients participated in the studies selected. Dobutamine stress echocardiography had the highest weighted sensitivity of 85% (95% confidence interval (CI) 74% to 97%) and a reasonable specificity of 70% (95% CI 62% to 79%) for predicting perioperative cardiac death and non-fatal myocardial infarction. On SROC analysis, there was a trend for dobutamine stress echocardiography to perform better than the other tests, but this only reached significance against myocardial perfusion scintigraphy (relative diagnostic odds ratio 5.5, 95% CI 2.0 to 14.9). CONCLUSIONS: On meta-analysis of six non-invasive tests, dobutamine stress echocardiography showed a positive trend towards better diagnostic performance than the other tests, but this was only significant in the comparison with myocardial perfusion scintigraphy. However, dobutamine stress echocardiography may be the favoured test in situations where there is valvar or left ventricular

With current constraints on health care resources and emphasis on value for money, new diagnostic imaging technologies must be assessed and their value demonstrated. The state of the art in the field of diagnostic imaging technology assessment advocates a hierarchical step-by-step approach. Although rigorous, such a hierarchical assessment is time-consuming, and, given the current rapid advances in technology, results are often too late to influence management and policy decisions. The purpose of this article is to discuss a study design in which development, assessment, and implementation of new diagnostic imaging technology take place concurrently in one integrated process. An empirically based pragmatic study design is proposed for imaging technology assessment. To minimize bias and enable comparison with current technology, a randomized controlled design is used whenever feasible and ethical. Outcome measures should reflect the clinical decision-making process based on imaging information and acceptance of the new test. Outcome measures can include additional imaging studies requested, costs of diagnostic work-up and treatment, physicians' confidence in therapeutic decision making, recruitment rate, and patient outcome measures related to the clinical problem. The key feature of the proposed study design is analysis of trends in outcome measures over time.

PURPOSE: To perform a meta-analysis of long-term results of balloon dilation and stent implantation in the treatment of femoropopliteal arterial disease. MATERIALS AND METHODS: The English-language literature was searched for studies published between 1993 and 2000. Inclusion criteria for articles were presentation of long-term primary patency rates, standard errors (explicitly reported or derivable), and baseline characteristics of the study population. Two reviewers independently extracted data, and discrepancies were resolved by consensus. Primary patency rates were combined by using a technique that allows adjustment for differences across study populations. Analyses were adjusted for lesion type and clinical indication. RESULTS: Nineteen studies met the inclusion criteria, representing 923 balloon dilations and 473 stent implantations. Combined 3-year patency rates after balloon dilation were 61% (standard error, 2.2%) for stenoses and claudication, 48% (standard error, 3.3%) for occlusions and claudication, 43% (standard error, 4.1%) for stenoses and critical ischemia, and 30% (standard error, 3.7%) for occlusions and critical ischemia. The 3-year patency rates after stent implantation were 63%-66% (standard error, 4.1%) and were independent of clinical indication and lesion type. Funnel plots demonstrated an asymmetric distribution of the data points associated with stent studies. CONCLUSION: Balloon dilation and stent implantation for claudication and stenosis yield similar long-term patency rates. For more severe femoropopliteal disease, the results of stent implantation seem more favorable. Publication bias could not be ruled out.

PURPOSE: To determine the criteria that would make use of an endovascular device cost-effective compared with bypass surgery and percutaneous transluminal angioplasty in the treatment of femoropopliteal arterial disease. MATERIALS AND METHODS: A decision model was developed to compare treatment with the use of a hypothetical endovascular device with established therapies. Cost-effectiveness from the perspective of the health care system was considered. Outcome measures were lifetime costs and quality-adjusted life-years. With the use of net health benefit calculations and threshold analysis, combinations of costs and patency rates were determined that would make the device cost-effective compared with established therapies. In subgroup and sensitivity analyses, the effect on decision-making of sex, age, indication, lesion type, procedural risk, and society's willingness to pay for incremental gain in health were explored. RESULTS: Use of a device that costs $3,000 would be cost-effective compared with bypass surgery for critical ischemia if the 5-year patency rate is 29%-46%. Use of the same device would be cost-effective compared with angioplasty for disabling claudication and stenosis if the 5-year patency rate is 69%-86%. CONCLUSION: The target combinations of costs and patency rates found in this study are probably attainable, and further development of such endovascular devices seems warranted.

PURPOSE: To summarize and compare the published data on gadolinium-enhanced magnetic resonance (MR) angiography and color-guided duplex ultrasonography (US) for the work-up for peripheral arterial disease. MATERIALS AND METHODS: Studies published between January 1984 and November 1998 were included if (a) gadolinium-enhanced MR angiography and/or color-guided duplex US were performed for evaluation of arterial stenoses and occlusions in the work-up for peripheral arterial disease of the lower extremities, (b) conventional angiography was the reference standard, and (c) absolute numbers of true-positive, false-negative, true-negative, and false-positive results were available or derivable. RESULTS: With a random effects model, pooled sensitivity for MR angiography (97.5% [95% CI: 95.7%, 99.3%]) was higher than that for duplex US (87.6% [95% CI: 84.4%, 90.8%]). Pooled specificities were similar: 96.2% (95% CI: 94.4%, 97.9%) for MR angiography and 94.7% (95% CI: 93.2%, 96.2%) for duplex US. Summary receiver operating characteristic analysis demonstrated better discriminatory power for MR angiography than for duplex US. Regression coefficients for MR angiography versus US were 1.67 (95% CI: -0.23, 3.56) with adjustment for covariates, 2.11 (95% CI: 0.12, 4.09) without such adjustment, and 1.73 (95% CI: 0.44, 3.02) with a random effects model. CONCLUSION: Gadolinium-enhanced MR angiography has better discriminatory power than does color-guided duplex US and is a highly sensitive and specific method, as compared with conventional angiography, for the work-up for peripheral arterial disease.

Objective: To examine which atherosclerotic risk factors are determinants for peripheral arterial disease (PAD), we performed a population-based study in 6450 subjects (40% men, 60% women) aged 55 years and older. Methods: The presence of PAD was assessed by measuring the ankle-arm systolic blood pressure index (AAI); PAD was considered present if the AAI was lower than 0.90 in either leg. In addition, a threshold AAI of 0.70 in either leg defined severe PAD. Results: Determinants strongly and independently associated with PAD were age of at least 75 years (odds ratio [OR], 1.2; 95% confidence interval [Cl], 1.0-1.6), fibrinogen level (OR, 1.5; 95% Cl, 1.3-1.7), cigarette smoking (OR, 2.8; 95% Cl, 2.3-3.4), diabetes mellitus (OR, 2.0; 95% Cl, 1.6-2.5), and systolic blood pressure (OR, 1.2; 95% Cl, 1.1-1.2). An inverse relation of high-density lipoprotein cholesterol level with PAD (OR, 0.7; 95% Cl, 0.5-0.8) was found. Similar results were demonstrated for severe PAD. Separate analyses for men and women did not demonstrate differences in risk factors for PAD. Conclusions: Assessment of a wide range of atherosclerotic risk factors enabled us to quantify the relative importance of each factor as determinant for PAD. In total, 69% of the occurrence of PAD is attributable to cardiovascular risk factors measured in our study; smoking accounted for most (etiologic fraction, 18.1%). The results suggest that preventive management of PAD should be directed at systolic blood pressure, fibrinogen level, smoking, high-density lipoprotein cholesterol level, and diabetes mellitus.

BACKGROUND: To assess the quality of life in patients with iliac artery occlusive disease, we compared primary stent placement versus primary angioplasty followed by selective stent placement in a multicenter randomized controlled trial. METHODS AND RESULTS: Quality-of-life assessments were completed by 254 patients in a telephone interview. Assessment measures consisted of the RAND 36-Item Health Survey 1.0, time tradeoff, standard gamble, rating scale, health utilities index, and EuroQol-5D. The interviews were performed before treatment and after 1, 3, 12, and 24 months. When the 2 treatments were compared, no significant difference was observed (P>0.05). All measurements showed a significant improvement in the quality of life after treatment (P<0.05). The RAND 36-Item Health Survey measures physical functioning, role limitations caused by physical problems, and bodily pain and the EuroQol-5D were the most sensitive to the impact of revascularization. CONCLUSIONS: Health-related quality of life improves equally after primary stent placement and primary angioplasty with selective stent placement in the treatment of intermittent claudication caused by iliac artery occlusive disease.

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The subjects of this thesis are decision analysis and receiver operating characteristic (ROC) methodology applied to radiological problems. This thesis is intended for those interested in applying