ACR Appropriateness Criteria ® imaging of mesenteric ischemia.

Mesenteric ischemia is a rare disease associated with high morbidity and mortality. Acute mesenteric ischemia is most commonly secondary to embolism followed by arterial thrombosis, nonocclusive ischemia, and less commonly venous thrombosis. Chronic mesenteric ischemia is almost always caused by atherosclerotic disease, with rare causes including fibromuscular dysplasia and vasculitis. The American College of Radiology Appropriateness Criteria are evidence-based guidelines for specific clinical conditions that are reviewed every 2 years by a multidisciplinary expert panel. The guideline development and review include an extensive analysis of current medical literature from peer reviewed journals and the application of a well-established consensus methodology (modified Delphi) to rate the appropriateness of imaging and treatment procedures by the panel. In those instances where evidence is lacking or not definitive, expert opinion may be used to recommend imaging or treatment. Patients with mesenteric ischemia usually present with nonspecific abdominal symptoms and laboratory findings. This document evaluates and rates the appropriateness of imaging to evaluate patients with clinically suspected mesenteric ischemia. While catheter-based angiography has been considered the reference standard and enables diagnosis and treatment, advances in computed tomography have made it a first-line test in many patients because it is a fast, widely available, and noninvasive study. Abdominal radiographs and ultrasound have a limited role in diagnosing mesenteric ischemia but are commonly the first ordered tests in patients with abdominal pain and may diagnose more common pathologies.

Detection of hepatic steatosis on contrast-enhanced CT images: diagnostic accuracy of identification of areas of presumed focal fatty sparing.

OBJECTIVE: The purpose of this article is to determine the diagnostic accuracy of identifying focal areas of increased density along the gallbladder fossa or in the periphery of segment IV for diagnosing hepatic steatosis. MATERIALS AND METHODS: Five hundred consecutive three-phase CT examinations were retrospectively evaluated. Two reference standards for hepatic steatosis were determined using the unenhanced CT examination: a liver-spleen attenuation difference of greater than 10 HU and the absolute attenuation of the liver less than 40 HU. The portal venous phase was independently analyzed by two radiologists. Hepatic steatosis was diagnosed on the contrast-enhanced images if there was increased attenuation in the liver, either at the gallbladder fossa or in the posterior medial aspect of segment IV, when compared with background liver parenchyma. RESULTS: The criterion of relative liver-spleen attenuation difference diagnosed 38 cases. The criterion of absolute liver attenuation less than 40 HU diagnosed 44 cases. Of these cases, hepatic steatosis was diagnosed on the portal venous phase in 23 cases (κ = 1.0), with no false-positive cases. The criterion of relative liver-spleen attenuation difference yielded sensitivity, specificity, positive predictive value, and negative predictive value of 60.5%, 100%, 100%, and 96.9%, respectively. The criterion of absolute liver attenuation less than 40 HU yielded sensitivity, specificity, positive predictive value, and negative predictive value of 52.5%, 100%, 100%, and 95.7%, respectively. CONCLUSION: Qualitative evaluation of the liver on a portal venous phase contrast-enhanced CT is highly specific for the diagnosis of hepatic steatosis; the sensitivity of the method, however, is rather low.

ACR Appropriateness Criteria(®) blunt chest trauma--suspected aortic injury.

The purpose of these guidelines is to recommend appropriate imaging for patients with blunt chest trauma. These patients are most often imaged in the emergency room, and thus emergency radiologists play a substantial role in prompt, accurate diagnoses that, in turn, can lead to life-saving interventions. The ACR Appropriateness Criteria® are evidence-based guidelines for specific clinical conditions that are reviewed every 2 years by a multidisciplinary expert panel. The guideline development and review include an extensive analysis of current medical literature from peer reviewed journals and the application of a well-established consensus methodology (modified Delphi) to rate the appropriateness of imaging and treatment procedures by the panel. In those instances where evidence is lacking or not definitive, expert opinion may be used to recommend imaging or treatment. Imaging largely focuses on the detection and exclusion of traumatic aortic injury; a large proportion of patients are victims of motor vehicle accidents. For those patients who survive the injury and come to emergency radiology, rapid, appropriate assessment of patients who require surgery is paramount.

Contrast opacification using a reduced volume of iodinated contrast material and low peak kilovoltage in pulmonary CT angiography: Objective and subjective evaluation.

OBJECTIVE: The purpose of our study was to evaluate whether a reduced volume of iodinated contrast material for pulmonary CT angiography (CTA) using a low peak kilovoltage (kVp) technique yields equivalent opacification in all vessels. MATERIALS AND METHODS: Four hundred fifty-two consecutive pulmonary CTA patients (265 women and 187 men; age range, 18-91 years; mean age, 56.2 years) were retrospectively evaluated. Patients were grouped into those receiving 125 mL (n = 229) and 75 mL (n = 223) of 370 mg I/mL iodinated contrast material. Low kVp was used in all patients. Hounsfield units were measured at lobar, posterobasal segment, posterobasal ramus, and medial basal subsegmental ramus in the left lower lobe. Three thoracic radiologists blinded to contrast dose independently and randomly evaluated the quality of enhancement using a 3-point scale at the same levels. The two-sample Student's t test was used to compare contrast opacification between groups; Spearman's correlation and the C-statistic were used to assess objective and subjective measurements. Interreader agreement was measured using Kendall's coefficient. RESULTS: Mean contrast opacification differences between 125 mL versus 75 mL were not statistically significant (p > 0.21) at the lobar, segmental, and posterior basal rami, although the mean trended (p = 0.07) toward higher opacification of the medial basal ramus among 75 mL patients. Across all four pulmonary artery segments, there was good concordance between subjective and objective measurements, significantly higher than the null value of 0.50 (p > 0.05). For subsegmental arteries, concordance between objective and subjective measures was greater for the 75 mL group (p < 0.05). There was good interreader concordance, with a concordance coefficient of 0.70 (95% CI, 0.66-0.74). CONCLUSION: Both objective and subjective measures of contrast opacification support a reduction from 125 to 75 mL of contrast medium required for pulmonary CTA.

Vascular enhancement and image quality of MDCT pulmonary angiography in 400 cases: comparison of standard and low kilovoltage settings.

OBJECTIVE: The purpose of this study was to investigate the vascular enhancement and image quality of pulmonary CT angiography performed with lower peak kilovoltage settings in a large patient sample. MATERIALS AND METHODS: This retrospective study was approved by our institutional review board, which waived the requirement for informed consent. Four hundred patients believed to have a pulmonary embolism were studied. All patients underwent 16- or 64-MDCT with automatic tube current modulation. The 200 patients in the standard peak kilovoltage group (mean age, 57 years; range, 22-95 years) underwent MDCT at 130 or 120 kVp. The 200 patients in the low peak kilovoltage group (mean age, 56 years; range, 21-92 years) underwent MDCT at 110 or 100 kVp. Vascular enhancement was evaluated by measurement of the attenuation value in the main pulmonary artery and segmental and subsegmental arteries. Image noise was quantified by measurement of the SD of the attenuation value in the main pulmonary artery. One blinded radiologist assessed image quality using visual scores. Wilcoxon's rank test was used to evaluate differences between the groups. RESULTS: Mean vascular enhancement in the main pulmonary artery had significantly higher attenuation values in the low peak kilovoltage group (376.1 +/- 102.9 HU) than in the standard peak kilovoltage group (309.2 +/- 94.8 HU) (p < 0.0001). Mean attenuation values in all measured segmental and subsegmental arteries were significantly higher in the low peak kilovoltage group than in the standard peak kilovoltage group (p < 0.0001). Image noise in the low peak kilovoltage group was significantly higher than in the standard peak kilovoltage group (p < 0.0001). There was no significant difference in the image quality scores of the two groups (p = 0.116). CONCLUSION: Lowering kilovoltage improved vascular enhancement without deterioration of image quality. The results of our study confirm previously reported preliminary findings.

ACR Appropriateness Criteria® Suspected Lower Extremity Deep Vein Thrombosis.

Suspected lower extremity deep venous thrombosis is a common clinical scenario which providers seek a reliable test to guide management. The importance of confidently making this diagnosis lies in the 50% to 60% risk of pulmonary embolism with untreated deep vein thrombosis and subsequent mortality of 25% to 30%, balanced with the risks of anticoagulation. The ACR Appropriateness Criteria Expert Panel on Vascular Imaging reviews the current literature regarding lower extremity deep venous thrombosis and compared various imaging modalities including ultrasound, MR venography, CT venography, and catheter venography. The American College of Radiology Appropriateness Criteria are evidence-based guidelines for specific clinical conditions that are reviewed annually by a multidisciplinary expert panel. The guideline development and revision include an extensive analysis of current medical literature from peer reviewed journals and the application of well-established methodologies (RAND/UCLA Appropriateness Method and Grading of Recommendations Assessment, Development, and Evaluation or GRADE) to rate the appropriateness of imaging and treatment procedures for specific clinical scenarios. In those instances where evidence is lacking or equivocal, expert opinion may supplement the available evidence to recommend imaging or treatment.

ACR Appropriateness Criteria® Suspected Thoracic Aortic Aneurysm.

Although the incidence of thoracic aortic aneurysm is on the rise, initial imaging diagnosis can present a challenge for many clinicians. Providers are faced with many imaging choices as part of the initial workup. Considering level of invasiveness, relative radiation level, and quality of associated diagnostic data, CT angiography and MR angiography are believed to be the most appropriate options for radiological diagnosis of suspected thoracic aortic aneurysm. The American College of Radiology Appropriateness Criteria are evidence-based guidelines for specific clinical conditions that are reviewed annually by a multidisciplinary expert panel. The guideline development and revision include an extensive analysis of current medical literature from peer reviewed journals and the application of well-established methodologies (RAND/UCLA Appropriateness Method and Grading of Recommendations Assessment, Development, and Evaluation or GRADE) to rate the appropriateness of imaging and treatment procedures for specific clinical scenarios. In those instances where evidence is lacking or equivocal, expert opinion may supplement the available evidence to recommend imaging or treatment.

Segmentation of the right ventricle in four chamber cine cardiac MR images using polar dynamic programming.

The four chamber plane is currently underutilized in the right ventricular segmentation community. Four chamber information can be useful to determine ventricular short axis stacks and provide a rough estimate of the right ventricle in short axis stacks. In this study, we develop and test a semi-automated technique for segmenting the right ventricle in four chamber cine cardiac magnetic resonance images. The three techniques that use minimum cost path algorithms were used. The algorithms are: Dijkstra's shortest path algorithm (Dijkstra), an A* algorithm that uses length, curvature and torsion into an active contour model (ALCT), and a variation of polar dynamic programming (PDP). The techniques are evaluated against the expert traces using 175 cardiac images from 7 patients. The evaluation first looks at mutual overlap metrics and then focuses on clinical measures such as fractional area change (FAC). The mean mutual overlap between the physician's traces ranged from 0.85 to 0.88. Using as reference physician 1's landmarks and traces (i.e., comparing the traces from physician 1 to the semi-automated segmentation using physician 1's landmarks), the PDP algorithm has a mean mutual overlap of 0.8970 compared to 0.8912 for ALCT and 0.8879 for Dijkstra. The mean mutual overlap between the BP regions generated by physician 1 and physician 2 landmarks are 0.9674, 0.9605 and 0.9531 for PDP, ALCT and Dijkstra, respectively. The FAC correlation coefficient between the physician's traces ranged from 0.73 to 0.93.

ACR Appropriateness Criteria® Imaging of Deep Inferior Epigastric Arteries for Surgical Planning (Breast Reconstruction Surgery).

Breast cancer is the most common malignancy in women in the United States. Breast reconstruction surgery is a commonly used therapy for patients with breast cancer. The technique for the deep inferior epigastric perforator flap uses a preserved rectus muscle, which decreases donor site morbidity. Accurate identification and measurement of the perforator branches of the deep inferior epigastric artery is pivotal during pre-operative planning so that the surgeon can prioritize the best vessel to use and ultimately improve clinical outcome. The American College of Radiology Appropriateness Criteria are evidence-based guidelines for specific clinical conditions that are reviewed annually by a multidisciplinary expert panel. The guideline development and revision include an extensive analysis of current medical literature from peer reviewed journals and the application of well-established methodologies (RAND/UCLA Appropriateness Method and Grading of Recommendations Assessment, Development, and Evaluation or GRADE) to rate the appropriateness of imaging and treatment procedures for specific clinical scenarios. In those instances where evidence is lacking or equivocal, expert opinion may supplement the available evidence to recommend imaging or treatment.

ACR Appropriateness Criteria® Nonvariceal Upper Gastrointestinal Bleeding.

Upper gastrointestinal bleeding (UGIB) remains a significant cause of morbidity and mortality with mortality rates as high as 14%. This document addresses the indications for imaging UGIB that is nonvariceal and unrelated to portal hypertension. The four variants are derived with respect to upper endoscopy. For the first three, it is presumed that upper endoscopy has been performed, with three potential initial outcomes: endoscopy reveals arterial bleeding source, endoscopy confirms UGIB without a clear source, and negative endoscopy. The fourth variant, "postsurgical and traumatic causes of UGIB; endoscopy contraindicated" is considered separately because upper endoscopy is not performed. When endoscopy identifies the presence and location of bleeding but bleeding cannot be controlled endoscopically, catheter-based arteriography with treatment is an appropriate next study. CT angiography (CTA) is comparable with angiography as a diagnostic next step. If endoscopy demonstrates a bleed but the endoscopist cannot identify the bleeding source, angiography or CTA can be typically performed and both are considered appropriate. In the event of an obscure UGIB, angiography and CTA have been shown to be equivalent in identifying the bleeding source; CT enterography may be an alternative to CTA to find an intermittent bleeding source. In the postoperative or traumatic setting when endoscopy is contraindicated, primary angiography, CTA, and CT with intravenous contrast are considered appropriate. The American College of Radiology Appropriateness Criteria are evidence-based guidelines for specific clinical conditions that are reviewed annually by a multidisciplinary expert panel. The guideline development and revision include an extensive analysis of current medical literature from peer reviewed journals and the application of well-established methodologies (RAND/UCLA Appropriateness Method and Grading of Recommendations Assessment, Development, and Evaluation or GRADE) to rate the appropriateness of imaging and treatment procedures for specific clinical scenarios. In those instances where evidence is lacking or equivocal, expert opinion may supplement the available evidence to recommend imaging or treatment.

ACR Appropriateness Criteria® Vascular Claudication-Assessment for Revascularization.

Vascular claudication is a symptom complex characterized by reproducible pain and weakness in an active muscle group due to peripheral arterial disease. Noninvasive hemodynamic tests such as the ankle brachial index, toe brachial index, segmental pressures, and pulse volume recordings are considered the first imaging modalities necessary to reliably establish the presence and severity of arterial obstructions. Vascular imaging is consequently used for diagnosing individual lesions and triaging patients for medical, percutaneous, or surgical intervention. Catheter angiography remains the reference standard for imaging the peripheral arteries, providing a dynamic and accurate depiction of the peripheral arteries. It is particularly useful when endovascular intervention is anticipated. When combined with noninvasive hemodynamic tests, however, noninvasive imaging, including ultrasound, CT angiography, and MR angiography, can also reliably confirm or exclude the presence of peripheral arterial disease. All modalities, however, have their own technical limitations when classifying the location, extent, and severity of disease. The American College of Radiology Appropriateness Criteria are evidence-based guidelines for specific clinical conditions that are reviewed annually by a multidisciplinary expert panel. The guideline development and revision include an extensive analysis of current medical literature from peer-reviewed journals and the application of well-established methodologies (RAND/UCLA Appropriateness Method and Grading of Recommendations Assessment, Development, and Evaluation or GRADE) to rate the appropriateness of imaging and treatment procedures for specific clinical scenarios. In those instances where evidence is lacking or equivocal, expert opinion may supplement the available evidence to recommend imaging or treatment.

ACR Appropriateness Criteria Clinically Suspected Pulmonary Arteriovenous Malformation.

Pulmonary arteriovenous malformations are often included in the differential diagnosis of common clinical presentations, including hypoxemia, hemoptysis, brain abscesses, and paradoxical stroke, as well as affecting 30% to 50% of patients with hereditary hemorrhagic telangiectasia (HHT). Various imaging studies are used in the diagnostic and screening settings, which have been reviewed by the ACR Appropriateness Criteria Vascular Imaging Panel. Pulmonary arteriovenous malformation screening in patients with HHT is commonly performed with transthoracic echocardiographic bubble study, followed by CT for positive cases. Although transthoracic echocardiographic bubble studies and radionuclide perfusion detect right-to-left shunts, they do not provide all of the information needed for treatment planning and may remain positive after embolization. Pulmonary angiography is appropriate for preintervention planning but not as an initial test. MR angiography has a potential role in younger patients with HHT who may require lifelong surveillance, despite lower spatial resolution compared with CT. The ACR Appropriateness Criteria are evidence-based guidelines for specific clinical conditions that are reviewed every three years by a multidisciplinary expert panel. The guideline development and review include an extensive analysis of current medical literature from peer-reviewed journals and the application of a well-established consensus methodology (modified Delphi) to rate the appropriateness of imaging and treatment procedures by the panel. In those instances in which evidence is lacking or not definitive, expert opinion may be used to recommend imaging or treatment.

ACR Appropriateness Criteria® nontraumatic aortic disease.

The American College of Radiology Appropriateness Criteria are evidence-based guidelines for specific clinical conditions that are reviewed every 3 years by a multidisciplinary expert panel. The guideline development and review include an extensive analysis of current medical literature from peer-reviewed journals and the application of a well-established consensus methodology (modified Delphi) to rate the appropriateness of imaging and treatment procedures by the panel. In those instances in which evidence is lacking or not definitive, expert opinion may be used to recommend imaging or treatment. In this document we provided guidelines for use of various imaging modalities for assessment of nontraumatic aortic diseases.

Pulmonary resections following prior definitive chemoradiation therapy are associated with acceptable survival.

OBJECTIVES: The benefits of salvage resection for lung cancer recurrence following high-dose curative-intent chemoradiation therapy are unclear. We assessed survival after salvage lung resection following definitive chemoradiation. METHODS: Medical records of patients undergoing lung cancer resections at our institution following definitive chemoradiation therapy were reviewed from June 2006 to August 2012. A multivariate Cox proportional model was used to assess the factors associated with improved survival. RESULTS: Fourteen patients had chemoradiation therapy before lung resection (pneumonectomy, lobectomy or segmentectomy). Pretherapy cancer stage was Stage III in 11 patients, Stage IV in 2 and Stage II in 1. Postoperative 2-year survival was 49%. Patients had a median disease-free interval before resection of 33 months. No variables were found to be associated with improved post-chemoradiation survival from the time of definitive treatment or postoperative survival. Complications occurred in 6 (43%) patients, with 2 of those complications directly attributable to post-chemoradiation changes. There were no perioperative deaths within 90 days. CONCLUSIONS: Salvage lung resection for recurrent lung cancer following definitive chemoradiation therapy is feasible and is associated with postoperative survival and complication rates that are reasonable.

Etiologies of bilateral pleural effusions.

BACKGROUND: To evaluate the safety, etiology and outcomes of patients undergoing bilateral thoracentesis. METHODS: This is a prospective cohort study of 100 consecutive patients who underwent bilateral thoracenteses in an academic medical center from July 2009 through November 2010. Pleural fluid characteristics and etiologies of the effusions were assessed. Mean differences in levels of fluid characteristics between right and left lungs were tested. Associations between fluid characteristics and occurrence of bilateral malignant effusions were evaluated. The rate of pneumothorax and other complications subsequent to bilateral thoracentesis was determined. RESULTS: Exudates were more common than transudates, and most effusions had multiple etiologies, with 83% having two or more etiologies. Bilateral malignant effusions occurred in 19 patients, were the most common single etiology of exudative effusions, and were associated with higher levels of protein and LDH in the pleural fluid. Among 200 thoracenteses performed with a bilateral procedure, seven resulted in pneumothoraces, three of which required chest tube drainage and four were ex vacuo. CONCLUSIONS: More often than not, there are multiple etiologies that contribute to pleural fluid formation, and of the combinations of etiologies observed congestive heart failure was the most frequent contributor. Exudative effusions are more common than transudates when bilateral effusions are present. Malignancy is a common etiology of exudative effusions. This study suggests that the overall complication rate following bilateral thoracentesis is low and the rate of pneumothorax subsequent to bilateral thoracentesis is comparable to unilateral thoracentesis.

ACR Appropriateness Criteria® pulsatile abdominal mass, suspected abdominal aortic aneurysm.

Clinical palpation of a pulsating abdominal mass alerts the clinician to the presence of a possible abdominal aortic aneurysm (AAA). Generally an arterial aneurysm is defined as a localized arterial dilatation ≥50% greater than the normal diameter. Imaging studies are important in diagnosing the cause of a pulsatile abdominal mass and, if an AAA is found, in determining its size and involvement of abdominal branches. Ultrasound (US) is the initial imaging modality of choice when a pulsatile abdominal mass is present. Noncontrast computed tomography (CT) may be substituted in patients for whom US is not suitable. When aneurysms have reached the size threshold for intervention or are clinically symptomatic, contrast-enhanced multidetector CT angiography (CTA) is the best diagnostic and preintervention planning study, accurately delineating the location, size, and extent of aneurysm and the involvement of branch vessels. Magnetic resonance angiography (MRA) may be substituted if CT cannot be performed. Catheter arteriography has some utility in patients with significant contraindications to both CTA and MRA. The American College of Radiology Appropriateness Criteria(®) are evidence-based guidelines for specific clinical conditions that are reviewed every 2 years by a multidisciplinary expert panel. The guideline development and review include an extensive analysis of current medical literature from peer reviewed journals and the application of a well-established consensus methodology (modified Delphi) to rate the appropriateness of imaging and treatment procedures by the panel. In those instances where evidence is lacking or not definitive, expert opinion may be used to recommend imaging or treatment.

ACR appropriateness criteria imaging for transcatheter aortic valve replacement.

Although aortic valve replacement is the definitive therapy for severe aortic stenosis, almost half of patients with severe aortic stenosis are unable to undergo conventional aortic valve replacement because of advanced age, comorbidities, or prohibitive surgical risk. Treatment options have been recently expanded with the introduction of catheter-based implantation of a bioprosthetic aortic valve, referred to as transcatheter aortic valve replacement. Because this procedure is characterized by lack of exposure of the operative field, image guidance plays a critical role in preprocedural planning. This guideline document evaluates several preintervention imaging examinations that focus on both imaging at the aortic valve plane and planning in the supravalvular aorta and iliofemoral system. The ACR Appropriateness Criteria are evidence-based guidelines for specific clinical conditions that are reviewed every 2 years by a multidisciplinary expert panel. The guideline development and review include an extensive analysis of current medical literature from peer-reviewed journals and the application of a well-established consensus methodology (modified Delphi) to rate the appropriateness of imaging and treatment procedures by the panel. In those instances in which evidence is lacking or not definitive, expert opinion may be used to recommend imaging or treatment.

Impact of adaptive statistical iterative reconstruction on radiation dose in evaluation of trauma patients.

BACKGROUND: A recent study showed that computed tomographic (CT) scans contributed 93% of radiation exposure of 177 patients admitted to our Level I trauma center. Adaptive statistical iterative reconstruction (ASIR) is an algorithm that reduces the noise level in reconstructed images and therefore allows the use of less ionizing radiation during CT scans without significantly affecting image quality. ASIR was instituted on all CT scans performed on trauma patients in June 2009. Our objective was to determine if implementation of ASIR reduced radiation dose without compromising patient outcomes. METHODS: We identified 300 patients activating the trauma system before and after the implementation of ASIR imaging. After applying inclusion criteria, 245 charts were reviewed. Baseline demographics, presenting characteristics, number of delayed diagnoses, and missed injuries were recorded. The postexamination volume CT dose index (CTDIvol) and dose-length product (DLP) reported by the scanner for CT scans of the chest, abdomen, and pelvis and CT scans of the brain and cervical spine were recorded. Subjective image quality was compared between the two groups. RESULTS: For CT scans of the chest, abdomen, and pelvis, the mean CTDIvol (17.1 mGy vs. 14.2 mGy; p < 0.001) and DLP (1,165 mGy·cm vs. 1,004 mGy·cm; p < 0.001) was lower for studies performed with ASIR. For CT scans of the brain and cervical spine, the mean CTDIvol (61.7 mGy vs. 49.6 mGy; p < 0.001) and DLP (1,327 mGy·cm vs. 1,067 mGy·cm; p < 0.001) was lower for studies performed with ASIR. There was no subjective difference in image quality between ASIR and non-ASIR scans. All CT scans were deemed of good or excellent image quality. There were no delayed diagnoses or missed injuries related to CT scanning identified in either group. CONCLUSION: Implementation of ASIR imaging for CT scans performed on trauma patients led to a nearly 20% reduction in ionizing radiation without compromising outcomes or image quality. LEVEL OF EVIDENCE: Therapeutic study, level IV.