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PURPOSE Despite the importance of training in ambulatory care settings for residents to acquire important competencies, little is known about the organizational and environmental factors influencing the relative amount of time primary care residents train in ambulatory care during residency. The authors examined factors associated with postgraduate year 1 (PGY-1) residents' ambulatory care training time in Accreditation Council for Graduate Medical Education (ACGME)-accredited primary care programs. METHOD U.S.-accredited family medicine (FM) and internal medicine (IM) programs' 2016-2017 National Graduate Medical Education (GME) Census data from 895 programs within 550 sponsoring institutions (representing 13,077 PGY-1s) were linked to the 2016 Centers for Medicare and Medicaid Services Cost Reports and 2015-2016 Area Health Resource File. Multilevel regression models examined the association of GME program characteristics, sponsoring institution characteristics, geography, and environmental factors with PGY-1 residents' percentage of time spent in ambulatory care. RESULTS PGY-1 mean (standard deviation, SD) percent time spent in ambulatory care was 25.4% (SD, 0.4) for both FM and IM programs. In adjusted analyses (% increase [standard error, SE]), larger faculty size (0.03% [SE, 0.01], P < .001), sponsoring institution's receipt of Teaching Health Center (THC) funding (6.6% (SE, 2.7), P < .01), and accreditation warnings (4.8% [SE, 2.5], P < .05) were associated with a greater proportion of PGY-1 time spent in ambulatory care. Programs caring for higher proportions of Medicare beneficiaries spent relatively less time in ambulatory care (< 0.5% [SE, 0.2], P < .01). CONCLUSIONS Ambulatory care time for PGY-1s varies among ACGME-accredited primary care residency programs due to the complex context and factors primary care GME programs operate under. Larger ACGME-accredited FM and IM programs and those receiving federal THC GME funding had relatively more PGY-1 time spent in ambulatory care settings. These findings inform policies to increase resident exposure in ambulatory care, potentially improving learning, competency achievement, and primary care access.

Objective: Recurrence after meningioma surgery may occur even after complete tumor resection (Simpson grade I). One possible cause may be the presence of remnant tumor cells that were left behind and not identified using microscope`s white light. Almost all meningiomas are aminolevulinic acid (5-ALA)[for full text, please go to the a.m. URL], 72. Jahrestagung der Deutschen Gesellschaft für Neurochirurgie (DGNC), Joint Meeting mit der Polnischen Gesellschaft für Neurochirurgie

A growing population of older adults and improved effective treatments for inflammatory rheumatic diseases will increase the demand for more healthcare resources that already struggle with staggering outpatient clinic waiting times. Transformative delivery care models that provide sustainable healthcare services are urgently needed to meet these challenges. In this mini-review article, a proposed Lifelong Treatment Model for a decentralized follow-up of outpatient clinic patients living with rheumatoid arthritis is presented and discussed.Our conceptual model follows four steps for a transformative care delivery model supported by an Integrated Practice Unit; (1) Diagnosis, (2) Treatment, (3) Patient Empowered Disease Management, and (4) Telehealth. Through an Integrated Practice Unit, a multidisciplinary team could collaborate with patients with rheumatoid arthritis to facilitate high-value care that addresses most important outcomes of the patients; (1) Early Remission, (2) Decentralization, (3) Improved Quality of Life, and (4) Lifelong Sustain Remission.The article also addresses the growing challenges for the healthcare delivery system today for patients with rheumatoid arthritis and proposes how to reduce outpatient clinic visits without compromising quality and safety.

There is a paucity of treatments that are capable of reliably and robustly improving cognitive function in adults with mood disorders. Glucagon-like peptide-1 is synthesized centrally and its receptors are abundantly expressed in neural circuits subserving cognitive function. We aimed to determine the effects of liraglutide, a GLP-1 receptor (GLP-1R) agonist, on objective measures of cognition in adults with a depressive or bipolar disorder.In this 4-week, pilot, open-label, domain-based study (e.g. cognition), we recruited 19 individuals with major depressive disorder (MDD) or bipolar disorder (BD) and an impairment in executive function, defined as a below-average performance in the Trail Making Test-B (TMTB). Liraglutide 1.8mg/day was added as an adjunct to existing pharmacotherapy.Participants had significant increases from baseline to week 4 in the TMTB standard score (age and education corrected) (Cohen's d=0.64, p=0.009) and in a composite Z-score comprising multiple cognitive tests (i.e. Digit Symbol Substitution Test, Rey Auditory Verbal Learning Test, Stroop test) (Cohen's d=0.77, p0.001). Neither changes in mood rating scales nor metabolic parameters were associated with changes in cognitive performance (all p0.05); however baseline insulin resistance (IR) and body mass index (BMI) moderated the changes in the composite Z-score (p=0.021 and p=0.046, respectively), indicating larger responses in individuals with higher IR and BMI at baseline. There was a significant increase in lipase (p0.001), but individual values were above the upper limit of normality.Small sample size, open-label design, lack of a placebo group.Liraglutide was safe and well tolerated by a sample of non-diabetic individuals with mood disorders and had beneficial effects on objective measures of cognitive function. Larger studies with controlled trial designs are necessary to confirm and expand the results described herein.

Background Morel-Lavallee lesions (MLLs) are rare internal degloving injuries typically caused by blunt traumatic injuries and most commonly occur around the hips and in association with pelvic or acetabular fractures. MLL is often overlooked in the setting of poly-trauma; therefore, clinicians must maintain a high degree of suspicion and be familiar with the management of such injuries, especially in obese poly-trauma patients. Case presentation We present a 30-year-old female pedestrian struck by a motor vehicle who sustained multiple long bone fractures, a mesenteric hematoma, and full-thickness abdominal skin friction burn which masked a significant underlying abdominal MLL. The internal degloving caused significant devascularization of the overlying soft tissue and skin which required surgical drainage of hematoma, abdominal wall reconstruction with tangential excision, allografting, negative pressure wound therapy, and ultimately autografting. Conclusion MLL is a rare, often overlooked, internal degloving injury. Surgeons must maintain a high index of suspicion when dealing with third degree friction burns as they may mask underlying injuries such as MLL, and a delay in diagnosis can lead to increased morbidity.

Background Secure messages exchanged between patients and family medicine residents via an electronic health record (EHR) could be used to assess residents' clinical and communication skills, but the mechanism is not well understood. Objective To design and test a secure messaging competency assessment for family medicine residents in a patient-centered medical home (PCMH). Methods Using the existing literature and evidence-based guidelines, we designed an assessment tool to evaluate secure messaging competency for family medicine residents training in a PCMH. Core faculty performed 2-stage validity and reliability testing (n = 2 and n = 9, respectively). A series of randomly selected EHR secure messages (n = 45) were assessed from a sample of 10 residents across all years of training. Results The secure message assessment tool provided data on a set of competencies and a framework for resident feedback. Assessment showed 10% (n = 2) of residents at the novice level, 50% (n = 10) as progressing, and 40% (n = 8) as proficient. The most common deficiencies for residents' secure messages related to communication rather than clinical competencies (n = 37 [90%] versus n = 4 [10%]). Interrater reliability testing ranged from 60% to 78% agreement and 20% to 44% disagreement. Disagreement centered on interpersonal communication factors. After 2 stages of testing, the assessment using residents' secure messages was incorporated into our existing evaluation process. Conclusions Assessing family medicine residents' secure messaging for patient encounters closed an evaluation gap in our family medicine program, and offered residents feedback on their clinical and communication skills in a PCMH.

INTRODUCTION Competence in using an electronic health record (EHR) is considered a critical skill for physicians practicing in patient-centered medical homes (PCMHs), but few studies have examined the impact of EHR training for residents preparing to practice in PCMHs. This study explored the educational outcomes associated with comprehensive EHR training for family medicine residents. METHODS The PCMH EHR training consisted of case-based routine clinic visits delivered to 3 resident cohorts (N = 18). Participants completed an EHR competency self-assessment between 2011 and 2016 (N = 127), examining 6 EHR/PCMH core skills. We compared baseline characteristics for residents by low vs high exposure to EHR training. Multivariate regression estimated whether self-reported competencies improved over time and whether high PCMH EHR training exposure was associated with incremental improvement in self-reported competencies over time. RESULTS Residents completed an average of 8.2 sessions: low-exposure residents averaged 5.3 sessions (standard deviation = 1.5), and high-exposure residents averaged 9.0 sessions (standard deviation = 0.9). High-exposed residents had higher posttest scores at training completion (84.4 vs 70.7). Over time, adjusted mean scores (confidence interval) for both groups improved (p < 0.001) from 12.2 (9.6-14.8), with low-exposed residents having greater score improvement (p < 0.001) because of their much lower baseline scores. CONCLUSION Comprehensive training designed to improve EHR competencies among residents practicing in a PCMH resulted in improved assessment scores. Our findings indicate EHR training as part of resident exposure to the PCMH measurably improves self-assessed competencies, even among residents less engaged in EHR training.

Implementing an innovation, such as offering new types of patient-physician encounters through the patient-centered medical home (PCMH) model while maintaining Accreditation Council for Graduate Medical Education (ACGME) accreditation standards (e.g., patient encounter minimums for trainees), is challenging.In 2009, the Group Health Family Medicine Residency (GHFMR) received an ACGME Program Experimentation and Innovation Project (PEIP) exception that redefined the minimum Family Medicine Resident Review Committee requirement to 1,400 face-to-face visits and 250 electronic visits (1 electronic visit defined as 3 secure message or telephone encounters). The authors report GHFMR residents' continuity clinic encounters, specifically volume, from 2006 through 2013 via pre- and post-PCMH implementation. They discuss the implications for leaders of high-performing practices who desire to innovate while maintaining accreditation.Post-PCMH residents had 20% more overall patient contact. The largest change in care delivery method included a large increase in secure messages between patients and residents. Pre-PCMH residents had more face-to-face encounters; however, post-PCMH residents had more contact for all types of patient care encounters (face-to-face, secure messaging, and telephone) per hour of clinic time.The ACGME PEIP exception, allowing the incorporation of the PCMH, facilitated an increase in patient access and immersed residents in primary care innovation (namely, practicing in a PCMH model during graduate medical education training). The next steps are to assess the effect of the PCMH on resident learning and clinical outcomes and to continue residents' access to training that keeps pace with today's health care delivery needs.

Cognitive deficits are a core feature across psychiatric disorders. Emerging evidence indicates that metabolic pathways are highly relevant for the substrates and phenomenology of the cognitive domain. Herein, we aimed to determine the effects of liraglutide, a GLP-1R agonist, on brain structural/volumetric parameters in adults with a mood disorder. This is the secondary analysis of a 4-week, pilot, proof-of-concept, open-label study. Participants (N=19) exhibiting impairments in executive function with either major depressive disorder (MDD) or bipolar disorder (BD) were recruited. Liraglutide 1.8mg/day was added as an adjunct to existing pharmacotherapy. Structural magnetic resonance imaging (MRI) scanning was obtained at baseline and endpoint. Results showed that at endpoint there was significant weight loss (mean: 3.15%; p

This study aimed to assess the types of vertebral segments at the thoracolumbar junction, as they relate to the most caudal ribs, to evaluate the reliability of this assessment using axial CT with curved planar reformatting (CPR) images, to describe the morphologic characteristics of a thoracolumbar transitional vertebra (TLTV), to introduce a new classification system for the TLTV and to evaluate the reliability of the classification system using axial CT with CPR images.This was a retrospective review of 744 consecutive patients who underwent spine CT imaging that included the thoracolumbar junction. Two radiologists (Readers 1 and 2) independently evaluated the axial CT with CPR images for all cases (n = 744). Each radiologist differentiated the vertebral segments at the thoracolumbar junction as TLTV or non-TLTV (thoracic segment or lumbar segment). In addition, each radiologist classified the 94 patients with the TLTV using a novel classification system. Interobserver agreement between the two radiologists regarding the differentiation of vertebral segments at the thoracolumbar junction was analysed with kappa statistics. Similarly, intra- and interobserver agreement regarding TLTV classification was analysed with kappa statistics.Interobserver agreement between the two readers with respect to the differentiation of vertebral segments at the thoracolumbar junction via axial CT with CPR images was nearly perfect (κ-value: 0.959). Interobserver agreement between the two readers with respect to TLTV classification using axial CT with CPR images was nearly perfect (κ-value: 0.846). In addition, intraobserver agreement for Reader 1 was also nearly perfect (κ-value: 0.877).Morphologic analysis of the thoracolumbar junction may help accurate spinal enumeration.Consideration of various variants at the thoracolumbar junction should help radiologists and clinicians to interpret the morphology of the thoracolumbar junction. This may facilitate communication with the referring clinician, thereby reducing the error in spinal enumeration.

BACKGROUND Transforming growth factor beta (TGF-beta) plays an important role in diabetic retinopathy. betaIG-H3 is a downstream target molecule of TGF-beta that may participate in the pathogenesis of diabetic retinopathy and in particular in the loss of pericytes during early pathological changes. METHODS We observed bovine retinal pericytes apoptosis and the increased expression of TGF-beta and betaIG-H3 induced by high concentrations of glucose in the cell culture media. An anti-TGF-beta antibody was used to block glucose-induced retinal pericytes apoptosis. Retinal pericytes were also transfected with cDNA encodings either wild-type or mutant betaIG-H3 lacking Arg-Gly-Asp (RGD) sequences in order to validate the effects of betaIG-H3 and RGD signalling on retinal pericytes apoptosis. RESULTS A cell death-detecting enzyme-linked immunosorbent assay revealed that 25 mM glucose significantly increased cell death compared with 5.5 mM glucose after 5 or 7 days of exposure (P < 0.01). High glucose significantly increased the TGF-beta levels as compared with 5.5 mM glucose after 5 days, and betaIG-H3 levels after 3, 5 and 7 days of exposure (P < 0.01). TGF-beta increased cell death and betaIG-H3 levels in a dose-dependent manner, with a maximal effect observed at 1 ng/mL. An anti-TGF-beta antibody nearly completely blocked high glucose-induced cell death. Wild-type betaIG-H3-transfected cells showed a significant increase in cell death as compared with mutant betaIG-H3-transfected (Mycb-c) cells, untransfected or mock-transfected cells. CONCLUSION These results suggest that hyperglycaemia-induced expression of TGF-beta and betaIG-H3 contributes to accelerated retinal pericytes apoptosis. betaIG-H3 induces pericytes apoptosis through its RGD motif, which may constitute an important pathogenic mechanism leading to pericytes loss in diabetic retinopathy.

Objective To assess the attitudes of Korean physicians toward hormone therapy (HT) after publication of the Women's Health Initiative (WHI) study. Design Self-administered questionnaires, consisting of 22 items, were sent by mail to the members of the Korean Society of Menopause. Results More than 95% of Korean physicians were aware of the WHI study. The HT prescription rate decreased by 16% after publication of the WHI report; approximately half of the physicians who continued prescribing HT changed their prescriptions. The largest decreases occurred in regimens using conjugated equine estrogens and medroxyprogesterone acetate, for which prescriptions of sequential and continuous-combined regimens decreased by 20.7% and 22.7%, respectively. In contrast, the prescription rate for tibolone increased by 3.6%. Approximately 30% of physicians changed from standard to low doses, and 67.8% shortened the duration of HT. After publication of the WHI report, the main reasons for not prescribing or discontinuing HT were patient refusal and increased risk of cardiovascular disease, rather than breast cancer risk. After publication of the WHI report, the number of physicians who prescribed alternative or complementary medicines increased, the rate of HT prescription for the prevention of osteoporosis decreased, and the number of postmenopausal outpatients decreased. Conclusions Despite the results of the WHI report, most Korean physicians who participated in this study continued prescribing HT; however, approximately half of those who continued prescribing HT changed their prescriptions. The greatest change occurred in regimens using conjugated equine estrogens and medroxyprogesterone acetate.

We present a unique thirty-nine year old woman with both Huntington's disease (HD) and spinocerebellar ataxia type 10 (SCA10). She has 48 CAG repeats in the HD gene and 2511 ATTCT repeats in the ATX10 gene. Although both conditions are repeat expansion diseases they are thought to have quite different pathogenic mechanisms. The symptomatic age of onset in this patient (mid30s) is within the expected range for her repeat expansion sizes for each condition, but we discuss the evidence that the two conditions may interact to produce a more severe cognitive phenotype than would be expected for either of the conditions independently. The subject has Amerindian background on the maternal side from Colombia, South America, thus adding a 5th country expressing SCA10, all with Amerindian ancestry.

[for full text, please go to the a.m. URL], 24. Jahrestagung der Deutschen Gesellschaft für Arterioskleroseforschung

We have identified a large expansion of an ATTCT repeat within intron 9 of ATXN10 on chromosome 22q13.31 as the genetic mutation of spinocerebellar ataxia type 10 (SCA10). Our subsequent studies indicated that neither a gain nor a loss of function of ataxin 10 is likely the major pathogenic mechanism of SCA10. Here, using SCA10 cells, and transfected cells and transgenic mouse brain expressing expanded intronic AUUCU repeats as disease models, we show evidence for a key pathogenic molecular mechanism of SCA10. First, we studied the fate of the mutant repeat RNA by in situ hybridization. A Cy3-(AGAAU)10 riboprobe detected expanded AUUCU repeats aggregated in foci in SCA10 cells. Pull-down and co-immunoprecipitation data suggested that expanded AUUCU repeats within the spliced intronic sequence strongly bind to hnRNP K. Co-localization of hnRNP K and the AUUCU repeat aggregates in the transgenic mouse brain and transfected cells confirmed this interaction. To examine the impact of this interaction on hnRNP K function, we performed RT–PCR analysis of a splicing-regulatory target of hnRNP K, and found diminished hnRNP K activity in SCA10 cells. Cells expressing expanded AUUCU repeats underwent apoptosis, which accompanied massive translocation of PKCδ to mitochondria and activation of caspase 3. Importantly, siRNA–mediated hnRNP K deficiency also caused the same apoptotic event in otherwise normal cells, and over-expression of hnRNP K rescued cells expressing expanded AUUCU repeats from apoptosis, suggesting that the loss of function of hnRNP K plays a key role in cell death of SCA10. These results suggest that the expanded AUUCU–repeat in the intronic RNA undergoes normal transcription and splicing, but causes apoptosis via an activation cascade involving a loss of hnRNP K activities, massive translocation of PKCδ to mitochondria, and caspase 3 activation., Author Summary In an earlier study, we showed that the mutation of spinocerebellar ataxia 10 (SCA10) is an enormous expansion of a gene segment, which contains a tandemly repeated 5-base (ATTCT) unit. Since SCA10 is the only known human disease that is proven to be caused by 5-base repeat expansion, it is important to learn how this novel class of mutation causes the disease. We found that the mutation produces an expanded RNA repeat, which aberrantly accumulates in SCA10 cells and interacts with a major RNA–binding protein. When we expressed expanded RNA repeats or decreased the RNA–binding protein level in cultured cells, either of these manipulations produced a specific type of cell death that is associated with a massive transfer of a key enzyme called protein kinase C delta to mitochondria. We also showed that either blocking the expanded AUUCU repeat or replenishing hnRNP K rescues cells from the cell death induced by the SCA10 mutation. Together, we conclude that the mutant RNA inactivates hnRNP K and kills cells by triggering the specific cell-death mechanism. Our data provide important clues for therapeutic intervention in SCA10.

The purpose of this study was to investigate compromised memory function of schizophrenia patients in comparison with temporal lobe epilepsy patients, whose memory impairments result from a clear lesion. The authors hypothesized that schizophrenia patients would show poorer immediate and delayed recall performances in verbal and visual memory tasks. The study sample consisted of a healthy comparison group of 30 subjects and three patient groups comprising 76 schizophrenia patients, 93 left temporal lobe epilepsy patients, and 72 right temporal lobe epilepsy patients. The authors assessed immediate recall, delayed recall, and delayed retention. Tasks were subdivided into two categories (easy and difficult), and then patient memory dysfunction was compared among the memory tests. The authors observed material-specific memory impairment, where the left temporal lobe epilepsy group showed severe verbal memory impairment and the right temporal lobe epilepsy group showed severe visual memory impairment. A moderate impairment was found in immediate and delayed verbal memory in schizophrenia patients, and the impairment of visual memory was amplified with delayed recall. Such a result can be interpreted not only as a generalized cognitive deficit, but also as an integrative dysfunction involving the mesial temporal and frontal lobes in the left and right hemispheres, whereby the lesion site cannot be determined selectively. Our results show that the selection of a memory task that cannot be influenced by verbal mediation is very important for analyzing memory dysfunction in schizophrenia patients.

Between 1995 and 1997, 1,675 HIV-positive men and women using complementary and alternative medicine (CAM) were enrolled into the Bastyr University AIDS Research Center's Alternative Medicine Care Outcomes in AIDS (AMCOA) study. Funded by the National Institutes of Health (NIH) Office of Alternative Medicine (OAM) and National Institute of Allergy and Infectious Diseases (NIAID), the AMCOA study collected information on participant demographics, health status and use of conventional and CAM therapies. Participants from 46 states completed a baseline questionnaire, while additional clinical information (such as CD4 count and HIV-RNA viral load) was obtained from laboratory records. AMCOA participants reported using more than 1,600 different types of CAM therapies (1,210 CAM substances, 282 CAM therapeutic activities and 119 CAM provider types) for treating HIV/AIDS. Approximately two-thirds (63% n = 1,054) of the AMCOA cohort reported using antiretroviral drug therapy (ART) during the six-months previous to completing the baseline questionnaire, while 37% (n = 621) indicated they were not using ART. Of those not using ART, 104 subjects reported never having used any conventional medications for their HIV and 12 subjects used only non-prescription diarrhoea medications. The most frequently reported CAM substances were vitamin C (63%), multiple vitamin and mineral supplements (54%), vitamin E (53%) and garlic (53%). CAM provider types most commonly consulted by the AMCOA cohort were massage therapists (49%), acupuncturists (45%), nutritionists (37%) and psychotherapists (35%). CAM activities most commonly used were aerobic exercise (63%), prayer (58%), massage (53%) and meditation (46%). The choice of CAM therapies among the AMCOA cohort does not appear to be solely based on scientific evidence of efficacy of individual therapies. The majority of AMCOA subjects could be characterized as using integrated medicine, since an overwhelming proportion of the cohort consult with both conventional and CAM providers and use both conventional and CAM medications, yet few subjects reported that their conventional and CAM providers work as a team. These data and this cohort set the stage for conducting studies of health status changes associated with specific CAM therapies.

Purpose : Our goal was to evaluate CT findings of tuberculous abscess in the retromammary region of the breast. Method : Four patients with tuberculosis extending from the retromammary region to the pleura were examined by CT and the findings were evaluated. All cases were also examined with mammography and two cases were evaluated with sonography. Diagnosis was confirmed by acid-fast bacillus stain, culture, and histologic examination. Results : Mammography showed relatively smoothly marginated, round mass density in two cases, nodular density in one, and focal bulging of the pectoral wall in one. A sonogram demonstrated in two cases a fistulous connection from the heterogeneous, fluid-containing lesion with floating internal debris in the retromammary region to the thoracic cavity. In all four cases, CT showed relatively smoothly marginated, inhomogeneous, hypodense lesions with surrounding rims of the cold abscess type. A direct fistulous connection from the retromammary lesion through the thoracic wall into the pleura was seen in two cases. Destroyed rib fragments within the abscess were noted in two cases. Conclusion : A tuberculous abscess in the retromammary region usually showed on CT a focal, smoothly marginated, inhomogeneous, hypodense lesion with a surrounding enhancing rim. A direct fistulous connection with the pleura or a destroyed rib fragment in the abscess as revealed by CT can be helpful in the differential diagnosis of other infectious types of retromammary abscess.

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Alectinib, a highly selective inhibitor of anaplastic lymphoma kinase (ALK), has shown systemic and central nervous system (CNS) efficacy in the treatment of ALK-positive non-small-cell lung cancer (NSCLC). We investigated alectinib as compared with crizotinib in patients with previously untreated, advanced ALK-positive NSCLC, including those with asymptomatic CNS disease. In a randomized, open-label, phase 3 trial, we randomly assigned 303 patients with previously untreated, advanced ALK-positive NSCLC to receive either alectinib (600 mg twice daily) or crizotinib (250 mg twice daily). The primary end point was investigator-assessed progression-free survival. Secondary end points were independent review committee-assessed progression-free survival, time to CNS progression, objective response rate, and overall survival. During a median follow-up of 17.6 months (crizotinib) and 18.6 months (alectinib), an event of disease progression or death occurred in 62 of 152 patients (41%) in the alectinib group and 102 of 151 patients (68%) in the crizotinib group. The rate of investigator-assessed progression-free survival was significantly higher with alectinib than with crizotinib (12-month event-free survival rate, 68.4% [95% confidence interval (CI), 61.0 to 75.9] with alectinib vs. 48.7% [95% CI, 40.4 to 56.9] with crizotinib; hazard ratio for disease progression or death, 0.47 [95% CI, 0.34 to 0.65]; P

The purpose of this phase III clinical trial was to compare two different extracellular contrast agents, 1.0 M gadobutrol and 0.5 M gadopentate dimeglumine, for magnetic resonance imaging (MRI) in patients with known or suspected focal renal lesions. Using a multicenter, single-blind, interindividual, randomized study design, both contrast agents were compared in a total of 471 patients regarding their diagnostic accuracy, sensitivity, and specificity to correctly classify focal lesions of the kidney. To test for noninferiority the diagnostic accuracy rates for both contrast agents were compared with CT results based on a blinded reading. The average diagnostic accuracy across the three blinded readers ('average reader') was 83.7% for gadobutrol and 87.3% for gadopentate dimeglumine. The increase in accuracy from precontrast to combined precontrast and postcontrast MRI was 8.0% for gadobutrol and 6.9% for gadopentate dimeglumine. Sensitivity of the average reader was 85.2% for gadobutrol and 88.7% for gadopentate dimeglumine. Specificity of the average reader was 82.1% for gadobutrol and 86.1% for gadopentate dimeglumine. In conclusion, this study documents evidence for the noninferiority of a single i.v. bolus injection of 1.0 M gadobutrol compared with 0.5 M gadopentate dimeglumine in the diagnostic assessment of renal lesions with CE-MRI.