[First results of the federal quality assurance group ("Arztliche Stelle") in radiotherapy in baden-württemberg: part 1]. / Erste Ergebnisse der Qualitätssicherung durch Arztliche Stellen in der Radiotherapie am Beispiel Baden-Württemberg: Teil 1.

PURPOSE: To evaluate the structure quality (medical staff, linear accelerators, and patients) of radiotherapy units based on the clinical audits by the "Arztliche Stelle" (this institution is based on federal German law) in Baden-Württemberg. MATERIAL AND METHODS: External audits (performed by at least two radiation oncologists, one radiation physicist, and a member of the administration) of recently completed charts by designated reviewers using appropriate checklists developed by the federal task group ("Arztliche Stelle") were used. RESULTS: In the interval from 2005 to 2007, 60 linear accelerators in 24 radiotherapy units served a population of approximately 10.7 million inhabitants (178,000 inhabitants/linear accelerator). 28,210 people with malignant tumors were treated in these units in 2007. These patients were served by 127 radiation oncologists, 83 radiation physicists, and 235 technologists. The ratio of patients irradiated annually to staff would become 222 (range 85-400) for a radiation oncologist, 339 for a radiation physicist (range 170-538), and 120 for a technologist (range 48-189). In five of seven departments (71%), new staff was employed following the recommendations of the auditors. CONCLUSION: Clinical audits by the "Arztliche Stelle" are highly effective to evaluate the structure quality of radiotherapy units. Based on these audits realistic data for staff requirements were gained. Making use of these data, guidelines for average minimum personnel necessary for good patient care were calculated. Personnel requirements may vary related to specific needs (teaching, research) of the treatment program and should be accounted for when discussing with the administration. The recommendations of the auditors of the "Arztliche Stelle" resulted in the new employment of additional staff.

First results of the federal quality assurance group ("Arztliche Stelle") in radiotherapy in Baden-Württemberg: part 2.

PURPOSE: Part 2 of this study presents the results of the clinical audits of the "Arztliche Stelle" (AS) concerning process quality in the radiation therapy units in Baden-Württemberg, Germany. MATERIAL AND METHODS: The process quality of nine main test groups (laws, organizations, technical equipment, GMP [Good Medical Practice] principles, radiotherapy, radiation procedure, follow-up, discharge report, physics) were questioned by the AS commission and evaluated in a four-stage classification (1-4; none to grave deficiencies). RESULTS: In 18 institutes (81%), the medical and physical-technical inspection, including radiation protection for patients and staff, revealed very high to high quality, safe treatment commensurate with current standards was guaranteed once the suggestions for improvement given by the experts had been implemented. In four institutes (18%), the inspection showed a still satisfactory quality but a shorter period for reinspection was recommended. The most frequent comments/deficiencies were found in staff structures (32%), in continuous education/training for staff (32%), in informed patient consent (41%), follow-up (45%), and/or a unclearly formulated discharge report for the referring physicians (45%). CONCLUSION: The medical and physical-technical examination of radiation treatment in the vast majority (81%) of the radiation therapy institutes in Baden-Württemberg showed a very high or high quality. Most of the comments and deficiencies concerned the sector of systematic continued training for staff, giving clear explanations to patients, structured follow-up, and the state of the medical discharge reports. These deficiencies, however, do not represent any immediate danger to the patient through any deficiencies in therapy. The experience gained by the AS could act as a model for quality improvement and could also be transmitted to other medical sectors to retain quality standards. The various specialist associations are called upon to gradually adopt the suggestions for quality improvements which are based on concrete as-is analyses by steadily aligning practice with theory. This would enable the steadily rising demands of quality assurance to be sustainably implemented through practicable models.

Morphologic and functional magnetic resonance imaging of renal artery stenosis: a multireader tricenter study.

The effect of combined morphologic and functional magnetic resonance (MR) imaging on the interobserver and intermodality variability for the grading of renal artery stenosis is assessed. In a randomized, blinded tricenter analysis, seven readers evaluated 43 renal arteries on x-ray digital subtraction angiography (DSA), 3D-Gadolinium MR angiography (3D-Gd-MRA), cine phase-contrast flow measurement (PC-flow), and a combined analysis of the last two. Interobserver variability was assessed for the grading of renal artery stenosis as well as regional vessel visibility. Intermodality variability for stenosis grading was analyzed in cases in which the readers agreed on the degree of stenosis in DSA. DSA had a substantial interobserver variability for the grading of stenosis (mean kappa kappa 0.64). 3D-Gd-MRA revealed a slightly improved interobserver variability but incorrectly graded 6 of 34 stenoses on a two-point scale (<50%, > or =50%). The combined approach of 3D-Gd-MRA and PC-flow revealed the best (P = 0.0003) interobserver variability (median kappa = 0.75) and almost perfect intermodality agreement with DSA (97% of cases). These findings were confirmed in a prospective analysis of 97 renal arteries. The vessel visibility of the renal artery ostium was significantly better in 3D-Gd-MRA than in DSA, whereas the visibility of the hilar and intrarenal vessels was significantly worse (P = 0.0001). A combined morphologic and functional MR examination significantly reduces interobserver variability and offers reliable and reproducible grading of renal artery stenosis based on stenosis morphology and hemodynamic changes. It can be considered a safe and noninvasive alternative for diagnostic DSA in cases that do not require assessment of intrarenal vessels.