915 resultados para Informed consent (Medical law)
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PURPOSE: To retrospectively evaluate the midterm patency rate of the nitinol (Viatorr, W.L. Gore and Associates, Flagstaff, Ariz) stent-graft for direct intrahepatic portacaval shunt (DIPS) creation. MATERIALS AND METHODS: Institutional Review Board approval for this retrospective HIPAA-compliant study was obtained with waiver of informed consent. DIPS was created in 18 men and one woman (median age, 54 years; range, 45-65 years) by using nitinol polytetrafluoroethylene (PTFE)-covered stent-grafts. The primary indications were intractable ascites (n = 14), acute variceal bleeding (n = 3), and hydrothorax (n = 2). Follow-up included Doppler ultrasonography at 1, 6, and 12 months and venography with manometry at 6-month intervals after the procedure. Shunt patency and cumulative survival were evaluated by using the Kaplan-Meier method and survival curves were plotted. Differences in mean portosystemic gradients (PSGs) were evaluated by using the Student t test. Multiple regression analysis for survival and DIPS patency were performed for the following parameters: Child-Pugh class, model of end-stage liver disease score, pre- and post-DIPS PSGs, pre-DIPS liver function tests, and pre-DIPS creatinine levels. RESULTS: DIPS creation was successful in all patients. Effective portal decompression and free antegrade shunt flow was achieved in all patients. Intraperitoneal bleeding occurred in one patient during the procedure and was controlled during the same procedure by placing a second nitinol stent-graft. The primary patency rate was 100% at all times during the follow-up period (range, 2 days to 30 months; mean, 256 days; median, 160 days). Flow restrictors were deployed in two (11%) of 19 patients. The 1-year mortality rate was 37% (seven of 19). CONCLUSION: Patency after DIPS creation with the nitinol PTFE-covered stent-graft was superior to that after TIPS with the nitinol stent-graft.
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PURPOSE: To determine the effect of two pairs of echo times (TEs) for in-phase (IP) and opposed-phase (OP) 3.0-T magnetic resonance (MR) imaging on (a) quantitative analysis prospectively in a phantom study and (b) diagnostic accuracy retrospectively in a clinical study of adrenal tumors, with use of various reference standards in the clinical study. MATERIALS AND METHODS: A fat-saline phantom was used to perform IP and OP 3.0-T MR imaging for various fat fractions. The institutional review board approved this HIPAA-compliant study, with waiver of informed consent. Single-breath-hold IP and OP 3.0-T MR images in 21 patients (14 women, seven men; mean age, 63 years) with 23 adrenal tumors (16 adenomas, six metastases, one adrenocortical carcinoma) were reviewed. The MR protocol involved two acquisition schemes: In scheme A, the first OP echo (approximately 1.5-msec TE) and the second IP echo (approximately 4.9-msec TE) were acquired. In scheme B, the first IP echo (approximately 2.4-msec TE) and the third OP echo (approximately 5.8-msec TE) were acquired. Quantitative analysis was performed, and analysis of variance was used to test for differences between adenomas and nonadenomas. RESULTS: In the phantom study, scheme B did not enable discrimination among voxels that had small amounts of fat. In the clinical study, no overlap in signal intensity (SI) index values between adenomas and nonadenomas was seen (P < .05) with scheme A. However, with scheme B, no overlap in the adrenal gland SI-to-liver SI ratio between adenomas and nonadenomas was seen (P < .05). With scheme B, no overlap in adrenal gland SI index-to-liver SI index ratio between adenomas and nonadenomas was seen (P < .05). CONCLUSION: This initial experience indicates SI index is the most reliable parameter for characterization of adrenal tumors with 3.0-T MR imaging when obtaining OP echo before IP echo. When acquiring IP echo before OP echo, however, nonadenomas can be mistaken as adenomas with use of the SI index value.
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PURPOSE: To prospectively determine if changes in intrarenal oxygenation during acute unilateral ureteral obstruction can be depicted with blood oxygen level-dependent (BOLD) magnetic resonance (MR) imaging. MATERIALS AND METHODS: The study was approved by the local ethics committee, and written informed consent was obtained from all patients. BOLD MR imaging was performed in 10 male patients (mean age, 45 years +/- 17 [standard deviation]; range, 20-73 years) with a distal unilateral ureteral calculus and in 10 healthy age-matched male volunteers to estimate R2*, which is inversely related to tissue Po(2). R2* values were determined in the cortex and medulla of the obstructed and the contralateral nonobstructed kidneys. To reduce external effects on R2*, the R2* ratio between the medulla and cortex was also analyzed. Statistical analysis was performed with nonparametric rank tests. P < .05 was considered to indicate a significant difference. RESULTS: All patients had significantly lower medullary and cortical R2* values in the obstructed kidney (median R2* in medulla, 10.9 sec(-1) [range, 9.1-14.3 sec(-1)]; median R2* in cortex, 10.4 sec(-1) [range, 9.7-11.3 sec(-1)]) than in the nonobstructed kidney (median R2* in medulla, 17.2 sec(-1) [range, 14.6-23.2 sec(-1)], P = .005; median R2* in cortex, 11.7 sec(-1) [range, 11.0-14.0 sec(-1)], P = .005); values in the obstructed kidneys were also significantly lower than values in the kidneys of healthy control subjects (median R2* in medulla, 16.1 sec(-1) [range, 13.9-18.1 sec(-1)], P < .001; median R2* in cortex, 11.6 sec(-1) [range, 10.5-12.9 sec(-1)], P < .001). R2* ratios in the obstructed kidneys (median, 1.06; range, 0.85-1.27) were significantly lower than those in the nonobstructed kidneys (median, 1.49; range, 1.26-1.71; P = .005) and those in the kidneys of healthy control subjects (median, 1.38; range, 1.23-1.47; P < .001). In contrast, R2* ratios in the nonobstructed kidneys of patients were significantly higher than those in kidneys of healthy control subjects (P = .01). CONCLUSION: Increased oxygen content in the renal cortex and medulla occurs with acute unilateral ureteral obstruction, suggesting reduced function of the affected kidney.
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PURPOSE: To prospectively determine the accuracy of 64-section computed tomographic (CT) angiography for the depiction of coronary artery disease (CAD) that induces perfusion defects at myocardial perfusion imaging with single photon emission computed tomography (SPECT), by using myocardial perfusion imaging as the reference standard. MATERIALS AND METHODS: All patients gave written informed consent after the study details, including radiation exposure, were explained. The study protocol was approved by the local institutional review board. In patients referred for elective conventional coronary angiography, an additional 64-section CT angiography study and a myocardial perfusion imaging study (1-day adenosine stress-rest protocol) with technetium 99m-tetrofosmin SPECT were performed before conventional angiography. Coronary artery diameter narrowing of 50% or greater at CT angiography was defined as stenosis and was compared with the myocardial perfusion imaging findings. Quantitative coronary angiography served as a reference standard for CT angiography. RESULTS: A total of 1093 coronary segments in 310 coronary arteries in 78 patients (mean age, 65 years +/- 9 [standard deviation]; 35 women) were analyzed. CT angiography revealed stenoses in 137 segments (13%) corresponding to 91 arteries (29%) in 46 patients (59%). SPECT revealed 14 reversible, 13 fixed, and six partially reversible defects in 31 patients (40%). Sensitivity, specificity, and negative and positive predictive values, respectively, of CT angiography in the detection of reversible myocardial perfusion imaging defects were 95%, 53%, 94%, and 58% on a per-patient basis and 95%, 75%, 96%, and 72% on a per-artery basis. Agreement between CT and conventional angiography was very good (96% and kappa = 0.92 for patient-based analysis, 93% and kappa = 0.84 for vessel-based analysis). CONCLUSION: Sixty-four-section CT angiography can help rule out hemodynamically relevant CAD in patients with intermediate to high pretest likelihood, although an abnormal CT angiography study is a poor predictor of ischemia.
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PURPOSE: To prospectively assess the depiction rate and morphologic features of myocardial bridging (MB) of coronary arteries with 64-section computed tomographic (CT) coronary angiography in comparison to conventional coronary angiography. MATERIALS AND METHODS: Patients were simultaneously enrolled in a prospective study comparing CT and conventional coronary angiography, for which ethics committee approval and informed consent were obtained. One hundred patients (38 women, 62 men; mean age, 63.8 years +/- 11.6 [standard deviation]) underwent 64-section CT and conventional coronary angiography. Fifty additional patients (19 women, 31 men; mean age, 59.2 years +/- 13.2) who underwent CT only were also included. CT images were analyzed for the direct signs length, depth, and degree of systolic compression, while conventional angiograms were analyzed for the indirect signs step down-step up phenomenon, milking effect, and systolic compression of the tunneled segment. Statistical analysis was performed with Pearson correlation analysis, the Wilcoxon two-sample test, and Fisher exact tests. RESULTS: MB was detected with CT in 26 (26%) of 100 patients and with conventional angiography in 12 patients (12%). Mean tunneled segment length and depth at CT (n = 150) were 24.3 mm +/- 10.0 and 2.6 mm +/- 0.8, respectively. Systolic compression in the 12 patients was 31.3% +/- 11.0 at CT and 28.2% +/- 10.5 at conventional angiography (r = 0.72, P < .001). With CT, a significant correlation was not found between systolic compression and length (r = 0.16, P = .25, n = 150) but was found with depth (r = 0.65, P < .01, n = 150) of the tunneled segment. In 14 patients in whom MB was found at CT but not at conventional angiography, length, depth, and systolic compression were significantly lower than in patients in whom both modalities depicted the anomaly (P < .001, P < .01, and P < .001, respectively). CONCLUSION: The depiction rate of MB is greater with 64-section CT coronary angiography than with conventional coronary angiography. The degree of systolic compression of MB significantly correlates with tunneled segment depth but not length.
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Intravenous thrombolysis (IVT) is the evidence-based treatment of acute ischemic stroke in the first 3 h after symptom onset (IVT 3-4.5 h: off-label use with informed consent of the patient). However, intra-arterial thrombolysis (IAT) results in higher recanalization rates of the middle cerebral artery compared to IVT. Therefore it seems reasonable to apply IAT in addition or instead of IVT up to 6 h after symptom onset.
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BACKGROUND: This study presents an evaluation of the preoperative and postoperative best corrected visual acuity (BCVA), as well as of the incidence of perioperative and postoperative complications after opacified hydrogel intraocular lens (IOL) exchange. PATIENTS AND METHODS: We exchanged opacified hydrogel IOLs (Hydroview H 60 M, Bausch ; Lomb) in 55 patients (55 eyes). Preoperative and postoperative BCVA were compared. Intraoperative and postoperative complications were recorded. Follow-up period ranged from 3 months to 24 months. RESULTS: Mean BCVA improved significantly from 0.05 preoperatively to 0.4 at 3 months postoperatively and to 0.2 at the end of the follow-up period. Forty patients (72.7 %) reported visual improvement. The procedure was uneventful in 30 eyes (54.5 %) with complete removal of the opacified IOL optics and haptics. Intraoperative complications included partial zonular dehiscence in 10 eyes (18.2 %), en block capsular bag-IOL extraction in 2 eyes (3.6 %), posterior capsule rupture in 2 eyes (3.6 %), hyphema in 3 eyes (5.5 %), retained haptics in 8 eyes (14.5 %). Postoperative complications included corneal decompensation in 5 eyes (9.1 %), cystoid macular edema in 15 eyes (27.3 %), elevated intraocular pressure in 6 eyes (10.9 %), and retinal detachment in 1 eye (1.8 %). CONCLUSIONS: Visual acuity improved after opacified hydrogel IOL exchange, however, coexistent ocular morbidity as well as the appearance of serious postoperative complications may not yield the expected results. For these reasons extensive informed consent is mandatory.
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PURPOSE: Despite technically successful surgery for diverticular disease, a significant group of patients who experience persistent or recurrent symptoms remains. This study was designed to determine the incidence and pattern of persistent symptoms and their association with peroperative parameters. METHODS: Follow-up (33 (range, 4-72) months) through structured interviews with patients who had surgery for diverticulitis in our department from December 1999 to November 2004 was conducted. Of 162 patients, 124 (76.5 percent) were available for follow-up. Nonparametric tests were used for comparison of patients who had undergone elective (n = 68) or emergency (n = 56) procedures. RESULTS: Of patients who had elective surgery, 25 percent suffered persistent symptoms, including painful constipation, painful abdominal distension, abdominal cramps, and frequent painful diarrhea. Neither the stage of disease (complicated or uncomplicated) nor the surgical technique (laparotomy or laparoscopy) were significantly related to the occurrence of symptoms. Recurrent diverticulitis was not observed. Similar results were obtained from comparisons with emergency patients. CONCLUSIONS: The prevalence of persistent symptoms after successful surgery for diverticular disease may be an additional reason to carefully discuss the indication for prophylactic surgery. In any case, preoperative counseling and informed consent regarding the possibility of persistent symptoms after prophylactic elective surgery is essential.
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PURPOSE: To prospectively assess the diagnostic accuracy of nonenhanced three-dimensional (3D) steady-state free precession (SSFP) magnetic resonance (MR) angiography for detection of renal artery stenosis (RAS), with breath-hold contrast material-enhanced MR angiography performed as the reference standard. MATERIALS AND METHODS: The study was local ethics committee approved; all patients gave written informed consent. Fifty-three patients (30 male, 23 female; mean age, 58 years) with arterial hypertension and suspected of having RAS were examined with 1.5-T 3D SSFP renal MR angiography. Stenosis grade, maximal visible vessel length, and subjective image quality were compared. Sensitivity, specificity, accuracy, and negative predictive value (NPV) were calculated on artery-by-artery and patient-by-patient bases. The significance of the results was assessed with the paired two-sided t test for continuous variables and with the marginal homogeneity test for categorical variables. Cohen kappa statistics were used to estimate interobserver agreement. RESULTS: One hundred eight renal arteries with 20 significant (>or=50%) stenoses were detected with contrast-enhanced MR angiography. At artery-by-artery analysis, sensitivity, specificity, accuracy, and NPV of nonenhanced SSFP MR angiography for RAS detection were 100%, 93%, 94%, and 100%, respectively, for observer 1 and 95%, 95%, 95%, and 99%, respectively, for observer 2. Corresponding patient-by-patient values were 100%, 92%, 94%, and 100%, respectively, for observer 1 and 100%, 95%, 96%, and 100%, respectively, for observer 2. Overestimation of stenosis grade with SSFP MR angiography resulted in six and four false-positive findings for readers 1 and 2, respectively. Mean maximal visible lengths of the renal arteries were 69.9 mm at contrast-enhanced MR angiography and 61.1 mm at SSFP MR angiography (P<.001). Both techniques yielded good to excellent image quality. CONCLUSION: Slab-selective inversion-prepared 3D SSFP MR angiography had high sensitivity, specificity, accuracy, and NPV for RAS detection, without the need for contrast material. However, RAS severity was overestimated in some patients.
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Improved pregnancy rates in IVF have led to increasing numbers of surplus embryos which can potentially be used for purposes like donation to another infertile couple or further research. Individuals report high levels of ambivalence concerning the donation of surplus embryos. This study examined which strategies infertile patients use to deal with this ambivalence when asked to evaluate potential dispositions of surplus embryos created during IVF. Guideline-based interviews with fertility patients were audio-recorded and transcribed verbatim. Following the principle of theoretical sampling, eight interviews were analysed by use of Grounded Theory. Analyses focused on processes of individual attitude formation. Strategies for handling ambivalence during attitude formation were identified: the six strategies comprise cognitive and communicative strategies, and were integrated into a model of attitude formation under ambivalence. As ambivalence is a relevant phenomenon in attitude formation within IVF treatment, assessment of ambivalence is strongly recommended in social science studies investigating ethical problems in patient care. In the context of informed consent, there is a need for individual counselling which draws attention to the conflicting values during attitude formation. Counsellors should be aware of the signs of and the strategies to deal with ambivalence.
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PURPOSE: To prospectively determine reproducibility of magnetic resonance (MR) angiography and MR spectroscopy of deoxymyoglobin in assessment of collateral vessels and tissue perfusion in patients with critical limb ischemia (CLI) and to follow changes in patients undergoing intramuscular vascular endothelial growth factor (pVEGF)-C gene therapy, percutaneous transluminal angioplasty, supervised exercise training, or no therapy. MATERIALS AND METHODS: Study and gene therapy protocols were approved, and all patients gave written informed consent. To determine repeatability and reproducibility, seven patients underwent MR angiography and five underwent MR spectroscopy. The techniques were used to judge disease progress in 12 other patients with or without therapy: MR angiography to help determine change in visualization of collateral vessels and MR spectroscopy to help assess change in perfusion at proximal and distal calf levels. MR angiographic results were subjectively analyzed by three blinded readers. Intraobserver variability was expressed as 95% confidence interval (CI) (n=7); interobserver variability, as kappa statistic (n=15). Reexamination variability of MR spectroscopy was given as 95% CI for subsequent recovery times, and correlation with disease extent was calculated with Kendall taub rank correlation. Fisher-Yates test was used to correlate changes with pressure measurements and clinical course. RESULTS: Intraobserver and interobserver concordance was sensitive for detection of collateral vessels. Intraobserver agreement was 85.7% (95% CI: 42.1%, 99.6%). Interobserver agreement was high for small collateral vessels (kappa=0.74, P <.001) and fair for large collateral vessels (kappa=0.36, P=.002). MR spectroscopy was reproducible (95% CI: +/-26 seconds for proximal, +/-21 seconds for distal) and showed a correlation with disease extent (proximal calf, taub=0.84, P <.001; distal calf, taub=0.68, P=.04). Small collateral vessels increased over time (P=.04) but did not correlate with pressure measurements and clinical course. Recovery time correlated with clinical course (proximal calf, P=.03; distal calf, P=.005). CONCLUSION: MR angiography and MR spectroscopy of deoxymyoglobin can help document changes in visualization of collateral vessels and tissue perfusion in patients with CLI.
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OBJECT: Preliminary experience with the C-Port Flex-A Anastomosis System (Cardica, Inc.) to enable rapid automated anastomosis has been reported in coronary artery bypass surgery. The goal of the current study was to define the feasibility and safety of this method for high-flow extracranial-intracranial (EC-IC) bypass surgery in a clinical series. METHODS: In a prospective study design, patients with symptomatic carotid artery (CA) occlusion were selected for C-Port-assisted high-flow EC-IC bypass surgery if they met the following criteria: 1) transient or moderate permanent symptoms of focal ischemia; 2) CA occlusion; 3) hemodynamic instability; and 4) had provided informed consent. Bypasses were done using a radial artery graft that was proximally anastomosed to the superficial temporal artery trunk, the cervical external, or common CA. All distal cerebral anastomoses were performed on M2 branches using the C-Port Flex-A system. RESULTS: Within 6 months, 10 patients were enrolled in the study. The distal automated anastomosis could be accomplished in all patients; the median temporary occlusion time was 16.6+/-3.4 minutes. Intraoperative digital subtraction angiography (DSA) confirmed good bypass function in 9 patients, and in 1 the anastomosis was classified as fair. There was 1 major perioperative complication that consisted of the creation of a pseudoaneurysm due to a hardware problem. In all but 1 case the bypass was shown to be patent on DSA after 7 days; furthermore, in 1 patient a late occlusion developed due to vasospasm after a sylvian hemorrhage. One-week follow-up DSA revealed transient asymptomatic extracranial spasm of the donor artery and the radial artery graft in 1 case. Two patients developed a limited zone of infarction on CT scanning during the follow-up course. CONCLUSIONS: In patients with symptomatic CA occlusion, C-Port Flex-A-assisted high-flow EC-IC bypass surgery is a technically feasible procedure. The system needs further modification to achieve a faster and safer anastomosis to enable a conclusive comparison with standard and laser-assisted methods for high-flow bypass surgery.
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PURPOSE: To prospectively assess the potential of noninvasive diffusion-weighted magnetic resonance (MR) imaging to depict changes in microperfusion and diffusion in patients with acute unilateral ureteral obstruction. MATERIALS AND METHODS: The local ethics committee approved the study protocol. Informed consent was obtained. Diffusion-weighted MR imaging was performed in 21 patients (two women, 19 men; mean age, 43 years +/- 10 [standard deviation]) with acute unilateral ureteral obstruction due to a calculus diagnosed at unenhanced computed tomography. A control group (one woman, 15 men; mean age, 44 years +/- 12) underwent the same MR protocol. Standard processing yielded an apparent diffusion coefficient (ADC) ADCT; the separation of microperfusion and diffusion contributions yielded the perfusion fraction FP and the pure diffusion coefficient ADCD. ADCT, ADCD, and FP were compared between obstructed and contralateral unobstructed kidneys and with control values. For statistical analysis, nonparametric rank tests were used. A P value of less than .05 was considered significant. RESULTS: No significant differences were observed between the ADCT of the medulla or cortex of the obstructed and unobstructed kidneys. Compared with control kidneys, only medullary ADCT was slightly increased in the obstructed kidney (P < .04). However, the ADCD in the medulla of the obstructed and unobstructed kidneys was significantly higher than that in control subjects (201 x 10(-5) mm2/sec +/- 16 and 199 x 10(-5) mm2/sec +/- 20 vs 189 x 10(-5) mm2/sec +/- 12; P < .008 and P < .03, respectively). FP of the cortex of the obstructed kidney was significantly lower than that in the unobstructed kidney (20.2% +/- 4.8 vs 24.0% +/- 5.8; P < .002); FP of the medulla was slightly lower in the obstructed kidney than in the unobstructed kidney (18.3% +/- 5.9 vs 20.7% +/- 6.4; P = .05). CONCLUSION: Diffusion-weighted MR imaging allows noninvasive detection of changes in renal perfusion and diffusion during acute unilateral ureteral obstruction, as exemplified in patients with a ureteral calculus.
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OBJECTIVE: To compare image quality and radiation dose of thoracoabdominal computed tomography (CT) angiography at 80 and 100 kVp and to assess the feasibility of reducing contrast medium volume from 60 to 45 mL at 80 kVp. MATERIALS AND METHODS: This retrospective study had institutional review board approval; informed consent was waived. Seventy-five patients who had undergone thoracoabdominal 64-section multidetector-row CT angiography were divided into 3 groups of 25 patients each. Patients of groups A (tube voltage, 100 kVp) and B (tube voltage, 80 kVp) received 60 mL of contrast medium at 4 mL/s. Patients of group C (tube voltage, 80 kVp) received 45 mL of contrast medium at 3 mL/s. Mean aortoiliac attenuation, image noise, and contrast-to-noise ratio were assessed. The measurement of radiation dose was based on the volume CT dose index. Three independent readers assessed the diagnostic image quality. RESULTS: Mean aortoiliac attenuation for group B (621.1 +/- 90.5 HU) was significantly greater than for groups A and C (485.2 +/- 110.5 HU and 483.1 +/- 119.8 HU; respectively) (P < 0.001). Mean image noise was significantly higher for groups B and C than for group A (P < 0.05). The contrast-to-noise ratio did not significantly differ between the groups (group A, 35.0 +/- 13.8; group B, 31.7 +/- 10.1; group C, 27.3 +/- 11.5; P = 0.08). Mean volume CT dose index in groups B and C (5.2 +/- 0.4 mGy and 4.9 +/- 0.3 mGy, respectively) were reduced by 23.5% and 27.9%, respectively, compared with group A (6.8 +/- 0.8 mGy) (P < 0.001). The average overall diagnostic image quality for the 3 groups was graded as good or better. The score for group A was significantly higher than that for group C (P < 0.01), no difference was seen between group A and B (P = 0.92). CONCLUSIONS: Reduction of tube voltage from 100 to 80 kVp for thoracoabdominal CT angiography significantly reduces radiation dose without compromising image quality. Reduction of contrast medium volume to 45 mL at 80 kVp resulted in lower but still diagnostically acceptable image quality.
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Evidence is mounting that potentially curative systemic adjuvant therapy for early-stage breast cancer may result in cognitive impairment. Five published studies have investigated cognitive function in this setting, and the consistent results of all five studies suggest an adverse effect of adjuvant chemotherapy. These studies are reviewed with particular attention to their methodologic limitations. For example, all five studies used cross-sectional designs, none controlled for possible confounding hormonal factors, and three examined patients who had not received a uniform chemotherapy regimen. The potential roles of chemotherapy-induced menopause and of adjuvant hormonal therapy in cognitive impairment are also discussed. Priorities for future research include confirmation of an effect of adjuvant chemotherapy in a study with a longitudinal design, closer examination of the potential contribution of hormonal factors, and similar studies on the effect of adjuvant therapy on cognitive function in other cancer types. If an effect of systemic adjuvant therapy on cognitive function is confirmed, such an effect will have implications for informed consent. It may also result in incorporation of objective measures of cognition in clinical trials of adjuvant therapy and in the investigation of preventive interventions that might minimize the impact of cognitive dysfunction after cancer treatment.