GC-MS based method as an alternative diagnostic to identify ruptured silicone gel-filled breast implants

Im Zuge des Bekanntwerdens im April bzw. Juni 2010, dass einige Silikonbrustimplantate (engl. silicone breast implants, SBI) der Hersteller Poly Implant Prothèse (PIP), Rofil Nederland B. V. und GfE Medizintechnik Industriesilikon beinhalten, gaben sowohl die französische Agentur für die Sicherheit von Gesundheitsprodukten als auch das Bundesinstitut für Arzneimittel- und Medizinprodukte im Winter 2011/2012 eine Empfehlung zum Implantataustausch heraus. Im Gegensatz zu medical-grade-SBI anderer Hersteller, wie Allergan und Mentor, weisen die PIP- und Rofil-SBI erhöhte Bruchtendenzen, erhöhte Raten bezüglich Gel-Bluten und erhöhte Konzentrationen an zyklischen, flüchtigen Methylsiloxanen (engl. cyclic volatile methylsiloxanes, cVMS) auf. In Europa wird in Voruntersuchungen für die Diagnostik defekter Implantate primär die Mammasonographie als Standardmethode eingesetzt, obwohl die Magnetresonanztomografie aufgrund ihrer hohen Sensitivität gerne als „Goldstandard“ bezeichnet wird. Diese Verfahren sind mit einem hohen finanziellen Aufwand für das Gesundheitssystem und mit einem zeitlichen Aufwand für den Patienten1 verbunden. Um eine schnelle Identifizierung von Implantatrupturen zu ermöglichen, wäre die Etablierung eines alternativen, nicht-invasiven und kostengünstigen Diagnoseverfahrens vorteilhaft. Zur Entwicklung einer alternativen Diagnostikmethode wurden Silikon-Gelproben sowie Humanproben von Frauen mit defekten und intakten Silikonimplantaten nach Extraktation mit Dichlormethan analysiert. Zur Identifizierung signifikanter Marker-Substanzen wurden im ersten Schritt screening-Verfahren unter Einsatz der komprehensiven zweidimensionalen Gaschromatographie gekoppelt an ein Quadrupol-Massenspektrometer (GCxGC-MS) zur Analyse dieser Matrices angewendet. Durch Abgleich mit analytischen Standards konnten die zyklischen flüchtigen Methylsiloxane (engl. cyclic volatile methylsiloxanes, cVMS) Octamethylcyclotetra (D4)-, Decamethylcyclopenta (D5)- und Dodecamethylcyclohexasiloxan (D6) eindeutig identifiziert werden. Im zweiten Schritt, wurden eine sensitive GC-MS-Methode auf Basis der large volume-Injektionstechnik zur Quantifizierung von cVMS in Vollblut entwickelt. Im Gegensatz zu den Vollblutproben der Kontrollperson und der Patienten mit intakten SBI, bei denen überwiegend Siloxan-Konzentrationen unterhalb der Bestimmungsgrenzen bzw. überhaupt nicht nachgewiesen werden konnten, wurden in den Vollblutproben der Patienten mit defekten SBI unterschiedlicher Hersteller Siloxan-Konzentrationen bis zu 0,57 ng D4/g Vollblut und 0,16 ng D6/g Vollblut detektiert. Nach Vergleich mit dem intraoperativen Implantatbefund lässt sich festhalten, dass es bei den mittels LVI-GC-MS analysierten 24 Fällen mit diesem Multikomponenten-Marker und unter Einhaltung der angegebenen Grenzwerte nur vier Fehldiagnosen gab. Dies entspricht einer Fehlerquote der entwickelten analytischen Diagnostikmethode von 17 % und ist damit um den Faktor 3 präziser als die Mammasonographie (Fehlquote 46 %).In April 2010, it was announced that SBI from the manufacturer “Poly Implant Prothèse” and “Rofil Medical Nederland B.V.” include industrial- instead of medical-grade silicone gel. Compared to silicone breast implants (SBI) from manufacturers such as Allergan and Mentor higher rupture tendencies, gel-bleeding rates and cyclic volatile methylsiloxanes (cVMS) concentrations are reported. To date, imaging methods, like mamma sonography (SONO) and magnetic resonance imaging (MRI), are used as diagnostic tool for detection of defect SBI. For logistic and cost reasons SONO, which is less precious than the “gold standard” MRI, is the commonly used clinical method. Under this point of view, it would be advantageous to establish a cost-effective, non-invasive and sensitive method for the identification of ruptured implants. Therefore, silicone-gel of SBI and human samples of women with intact and ruptured SBI, like capsular tissue and blood, were investigated after dichloromethane extraction. In a first step screening-methods using comprehensive two-dimensional gas chromatography coupled to a quadrupole mass spectrometer (GCxGC/MS) were applied to identify significant marker substances in these human matrices. In a second step, a sensitive method based on large volume injection-GC/MS was developed to quantify cVMS in human blood. In contrast to women with intact SBI in blood of women with ruptured SBI higher octamethylcyclotetra-siloxane- (D4) and dodecamethylcyclohexasiloxane (D6)-concentrations up to 0.57 ng D4/g and 0.16 ng D6/g blood could be analyzed. With concentrations above 0.18 ng D4/g and 0.10 ng D6/g blood as significant criteria, this developed analytical method for the identification of ruptured SBI shows a three-times higher precision (error rate 17 %) than SONO (error rate 46 %)

Motivational Interviewing in an ordinary clinical setting: A controlled clinical trial at the Swedish National Tobacco Quitline

AbstractIntroductionThe present study aimed to assess the effect of adding Motivational Interviewing (MI) to the first session of an effective smoking cessation treatment protocol in an ordinary clinical setting: the Swedish National Tobacco Quitline (SNTQ).MethodThe study was designed as a controlled clinical trial. Between September 2005 and October 2006, 772 clients accepted the invitation to participate in the study and were semi-randomised to either standard treatment (ST) or MI. The primary outcome measures were self-reported 7-day point prevalence abstinence and 6-month continuous abstinence.ResultsAt 12-month follow-up, the 772 clients were included in an intention to treat analysis. Of the clients allocated to MI, 57/296 (19%) reported 6-month continuous abstinence compared to 66/476 (14%) of the clients allocated to ST (OR 1.48, 95% CI 1.00–2.19; P=.047).ConclusionsIntegrating MI into a cognitive behavioural therapy-based smoking cessation counselling in an ordinary clinical setting at a tobacco quitline increased client 6-month continuous abstinence rates by 5%

Whole-body magnetic resonance imaging in children – how and why? A systematic review

Whole-body magnetic resonance imaging (MRI) is increasingly being used for a number of indications. Our aim was to review and describe indications and scan protocols for diagnostic value of whole-body MRI for multifocal disease in children and adolescents, we conducted a systematic search in Medline, Embase and Cochrane for all published papers until November 2018. Relevant subject headings and free text words were used for the following concepts: 1) whole-body, 2) magnetic resonance imaging and 3) child and/or adolescent. Included were papers in English with a relevant study design that reported on the use and/or findings from whole-body MRI examinations in children and adolescents. This review includes 54 of 1,609 papers identified from literature searches. Chronic nonbacterial osteomyelitis, lymphoma and metastasis were the most frequent indications for performing a whole-body MRI. The typical protocol included a coronal STIR (short tau inversion recovery) sequence with or without a coronal T1-weighted sequence. Numerous studies lacked sufficient data for calculating images resolution and only a few studies reported the acquired voxel volume, making it impossible for others to reproduce the protocol/images. Only a minority of the included papers assessed reliability tests and none of the studies documented whether the use of whole-body MRI affected mortality and/or morbidity. Our systematic review confirms significant variability of technique and the lack of proven validity of MRI findings. The information could potentially be used to boost attempts towards standardization of technique, reporting and guidelines development

Whole-body MRI in children and adolescents: Can T2-weighted Dixon fat-only images replace standard T1-weighted images in the assessment of bone marrow?

Objective: When performing whole-body MRI for bone marrow assessment in children, optimizing scan time is crucial. The aim was to compare T2 Dixon fat-only and TSE T1-weighted sequences in the assessment of bone marrow high signal areas seen on T2 Dixon water-only in healthy children and adolescents. Materials and methods: Whole-body MRIs from 196 healthy children and adolescents aged 6 to 19 years (mean 12.0) were obtained including T2 TSE Dixon and T1 TSE-weighted images. Areas with increased signal on T2 Dixon water-only images were scored using a novel, validated scoring system and classified into “minor” or “major” findings according to size and intensity, where “major” referred to changes easily being misdiagnosed as pathology in a clinical setting. Areas were assessed for low signal on T2 Dixon fat-only images and, after at least three weeks to avoid recall bias, on the T1-weighted sequence by two experienced pediatric radiologists. Results: 1250 high signal areas were evaluated on T2 Dixon water-only images. In 1159/1250 (92.7%) low signal was seen on both T2 Dixon fat-only and T1-weighted sequences while in 24 (1.9%) it was not present on either sequence, with an absolute agreement of 94.6%. Discordant findings were found in 67 areas, of which in 18 (1.5%) low signal was visible on T1-weighted images alone and in 49 (3.9%) on T2 Dixon fat-only alone. The overall kappa value between the two sequences was 0.39. The agreement was higher for major as compared to minor findings (kappa values of 0.69 and 0.29, respectively) and higher for the older age groups. Conclusion: T2 Dixon fat-only can replace T1-weighted sequence on whole-body MRI for bone marrow assessment in children over the age of nine, thus reducing scan time

Whole body magnetic resonance imaging in healthy children and adolescents: Bone marrow appearances of the appendicular skeleton

Objective: To describe the appearances of bone marrow in the appendicular skeleton on fat-suppressed T2- weighted sequences as assessed by whole-body MRI in healthy and asymptomatic children and adolescents. Material and methods: Following ethical approval, we assessed the bone marrow of the extremities on water-only Dixon T2-weighted images as part of a whole-body MRI in 196 healthy and asymptomatic children aged 5–19 years. Based on a newly devised and validated scoring system, we graded intensity (0–2 scale) and extension (1–4 scale) of focal high signal bone marrow areas, and divided them into minor or major findings, based on intensity and extension, reflecting their potential conspicuousness in a clinical setting. Results: In the upper extremity, we registered 366 areas with increased signal whereof 79 were major findings. In the lower extremities there were 675 areas of increased signal of which 340 were major findings. Hundred-andfifteen (58.79%) individuals had at least one major finding, mainly located in the hand and proximal humerus, and the feet and knees. We found no differences according to gender, reported hours of sports activity, handedness, or age group, except for more minor findings in the upper extremities amongst 15–18-year-olds as compared to those aged 5–8 years. Conclusion: Focal areas of high signal intensity on whole-body MRI, T2-weighted fat suppressed images that, in a clinical setting could cause concern, were seen in more than half of healthy, asymptomatic children and adolescents. Awareness of this is important when interpreting whole-body MRI in this age group, particularly in the assessment of clinically silent lesions

Lähikuva lähiöstä! – Itä-Porin kulttuurikartoitus ja toimenpidesuunitelma

Itä-Porin kerrostalolähiöt ovat Porin suurin lähiöalue. Ne syntyivät kasvavan ja teollistuvan kaupungin tarpeisiin ja edustavat aikansa aluerakentamista. Asukkaat ja rakennuskanta ovat vuosien varrella ikääntyneet, mutta alueiden rauhallisuutta ja luontoa arvostetaan. Lähiöiden asukastoiminta on monipuolista, Itä-Porista löytyy myös vireää taidetoimintaa ja arvokasta rakennusperintöä. Turun yliopiston maisemantutkimus on tehnyt Itä-Porin lähiöiden laajan kulttuurikartoituksen, jossa kerättiin tietoa asukasryhmistä, toiminnasta, ympäristöstä ja tarpeista. Tulosten pohjalta tuotettiin yhdessä asukkaiden, taiteilijaryhmä T.E.H.D.A.S. ry:n ja kaupungin edustajien kanssa toimenpidesuunnitelma lähiöiden kehittämiseksi. Itä-Porin tulevaisuudelle on tärkeää, että lähiöitä kehitetään tasapuolisesti muun kaupungin kanssa. Tähän vaaditaan kaikkien osapuolten panostusta ja yhteistyötä.</p

European recommendations on practices in pediatric neuroradiology: consensus document from the European Society of Neuroradiology (ESNR), European Society of Paediatric Radiology (ESPR) and European Union of Medical Specialists Division of Neuroradiology (UEMS)

Pediatric neuroradiology is a subspecialty within radiology, with possible pathways to train within the discipline from neuroradiology or pediatric radiology. Formalized pediatric neuroradiology training programs are not available in most European countries. We aimed to construct a European consensus document providing recommendations for the safe practice of pediatric neuroradiology. We particularly emphasize imaging techniques that should be available, optimal site conditions and facilities, recommended team requirements and specific indications and protocol modifications for each imaging modality employed for pediatric neuroradiology studies. The present document serves as guidance to the optimal setup and organization for carrying out pediatric neuroradiology diagnostic and interventional procedures. Clinical activities should always be carried out in full agreement with national provisions and regulations. Continued education of all parties involved is a requisite for preserving pediatric neuroradiology practice at a high level

Operationssjuksköterskors upplevelser av risker med att utsättas för blodburen smitta

Validerat; 20101217 (root