Post-print: Assessing risk of contamination in psychological therapy trial protocols

2019 ◽  
Author(s):  
Pamela Charlotte Jacobsen ◽  
Lisa Wood

We developed and piloted a simple framework, to help people identify contamination risk when writing protocols for psychological therapy trials. Contamination means people in the control arm getting the treatment, or aspects of the treatment, intended for people in the intervention arm. We tested the framework out on 100 trial protocols registered on the ISRCTN trial registry (isrctn.com). We found that only 14 out of the 100 protocols we looked at had a potential risk of contamination via any of the sources identified in the framework. Most of these trial protocols had already identified the potential contamination risk and had put in place appropriate design adaptations to help guard against the risk.

2015 ◽  
Vol 152 ◽  
pp. 170-176 ◽  
Author(s):  
Katherine Berry ◽  
Lynsey Gregg ◽  
Rosalyn Hartwell ◽  
Gillian Haddock ◽  
Mike Fitzsimmons ◽  
...  

2018 ◽  
Vol 6 (4) ◽  
pp. 126 ◽  
Author(s):  
Bianca Varcasia ◽  
Francesco Tomassetti ◽  
Laura De Santis ◽  
Fabiola Di Giamberardino ◽  
Sarah Lovari ◽  
...  

The aim of this study was to determine the prevalence of Shiga toxin-producing Escherichia coli in fresh beef marketed in 2017 in 13 regions of Italy, to evaluate the potential risk to human health. According to the ISO/TS 13136:2012 standard, 239 samples were analysed and nine were STEC positive, from which 20 strains were isolated. The STEC-positive samples were obtained from Calabria (n = 1), Campania (n = 1), Lazio (n = 2), Liguria (n = 1), Lombardia (n = 1) and Veneto (n = 3). All STEC strains were analysed for serogroups O26, O45, O55, O91, O103, O104, O111, O113, O121, O128, O145, O146 and O157, using Real-Time PCR. Three serogroups were identified amongst the 20 strains: O91 (n = 5), O113 (n = 2), and O157 (n = 1); the O-group for each of the 12 remaining STEC strains was not identified. Six stx subtypes were detected: stx1a, stx1c, stx2a, stx2b, stx2c and stx2d. Subtype stx2c was the most common, followed by stx2d and stx2b. Subtype stx2a was identified in only one eae-negative strain and occurred in combination with stx1a, stx1c and stx2b. The presence in meat of STEC strains being potentially harmful to human health shows the importance, during harvest, of implementing additional measures to reduce contamination risk.


VASA ◽  
2011 ◽  
Vol 40 (4) ◽  
pp. 327-332 ◽  
Author(s):  
Gabrielli ◽  
Rosati ◽  
Vitale ◽  
Millarelli ◽  
Siani ◽  
...  

Venous aneurysms are uncommon but they can have devastating consequences, including pulmonary embolism, other thromboembolic events and death. We report six cases of venous aneurysm of the extremities, in which the first sign of presence was acute pulmonary embolism. Surgical resection is recommended whenever possible. Our experience suggests that prophylactic surgery is cautiously recommended for low-risk patients with venous aneurysms of the abdomen and strongly recommended for extremity deep and superficial venous aneurysms for their potential risk of developing thromboembolic complications despite adequate anticoagulation. Other venous aneurysms should be excised only if they are symptomatic or enlarging.


Swiss Surgery ◽  
2000 ◽  
Vol 6 (2) ◽  
pp. 65-68
Author(s):  
Mueller ◽  
Tevaearai ◽  
Genton ◽  
Bettex ◽  
von Segesser

Les effets morphologiques et fonctionnels de la revascularisation transmyocardique au laser (RTML) sont analysés en conditions aiguës sur un modèle porcin. La paroi latérale du ventricule gauche de 15 porcs (poids moyen: 73 +/- 4kg) a été percée de 10 canaux laser (laser: Ho-YAG; longueur d'onde: 2.1 u, diamètre de la sonde: 1.75 mm). Une échocardiographie a été effectuée avant, ainsi que 5 min et 30 min après la procédure. Les paramètres échocardiographiques ont été enregistrés en court axe à la hauteur des canaux laser. Ils comprenaient la fraction d'éjection, la fraction de raccourcissement et la motilité segmentaire de la région lasérisée (échelle de 0 à 3: 0 = normal, 1 = hypokinésie, 2 = akinésie, 3 = dyskinésie). Après sacrifice de l'animal, la région lasérisée a été coupée dans un plan perpendiculaire aux canaux pour histologie et analyse morphométrique. Après 5 min, tous les index échocardiographiques ont montré une aggravation significative par rapport aux valeurs de base (p < 0.01). Après 30 min, plus aucun des paramètres ne présentait de variation significative par rapport aux valeurs de base. La surface de section des lésions mesurait 8.8 +/- 2.4 mm2 soit plus du triple de celle de la sonde laser elle-même (p < 0.01). En conditions aiguës, les lésions dues à la sonde de RTML sont nettement plus grande que la sonde elle-même et entraînent une baisse transitoire de la contractilité segmentaire sur un coeur sain. Ces résultats suggèrent que la RTML doit être utilisée avec prudence en clinique chez les patients avec une mauvaise fonction ventriculaire.


1990 ◽  
Vol 63 (01) ◽  
pp. 013-015 ◽  
Author(s):  
E J Johnson ◽  
C R M Prentice ◽  
L A Parapia

SummaryAntithrombin III (ATIII) deficiency is one of the few known abnormalities of the coagulation system known to predispose to venous thromboembolism but its relation to arterial disease is not established. We describe two related patients with this disorder, both of whom suffered arterial thrombotic events, at an early age. Both patients had other potential risk factors, though these would normally be considered unlikely to lead to such catastrophic events at such an age. Thrombosis due to ATIII deficiency is potentially preventable, and this diagnosis should be sought more frequently in patients with arterial thromboembolism, particularly if occurring at a young age. In addition, in patients with known ATIII deficiency, other risk factors for arterial disease should be eliminated, if possible. In particular, these patients should be counselled against smoking.


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