Do radiological research articles apply the term "pilot study" correctly? Systematic review.

AIM: To determine what proportion of radiological studies used the term "pilot" correctly. MATERIAL AND METHODS: Indexed studies describing themselves as a "pilot" in their title were identified from four indexed radiological journals. The aim was to identify 20 consecutive, eligible studies from each journal, as this sample size was deemed sufficient to be representative as to how this methodological description was employed by authors of radiological articles. Data were extracted relating to study design and data presented. The review was reported according to PRISMA guidelines. RESULTS: The search string used identified 658 records across the four targeted journals. Ultimately, 78 reviews describing 5,572 patients were selected for systematic review. Median sample size was just 20 patients. No individual study qualified as a genuine pilot study when assessed against the a priori criteria. In reality, the large majority (66 studies, 84.6%) were framed as studies of diagnostic test accuracy. A significant proportion (21 studies, 26.9%) was retrospective, and the overwhelming majority were conducted in single centres (76 centres, 94.7%). Most (55 studies, 70.5%) stated no rationale for their sample size, and no study presented a formal power calculation. CONCLUSION: Radiological "pilot" studies are mostly underpowered studies of diagnostic test accuracy. In order to have scientific credibility, authors, reviewers, and editors of radiological journals are encouraged to familiarise themselves with different methodological study designs and their precise implications.

Clinical application of bilateral high temporal and spatial resolution dynamic contrast-enhanced magnetic resonance imaging of the breast at 7 T.

OBJECTIVE: The objective of our study was to evaluate the clinical application of bilateral high spatial and temporal resolution dynamic contrast-enhanced magnetic resonance imaging (HR DCE-MRI) of the breast at 7 T. METHODS: Following institutional review board approval 23 patients with a breast lesion (BIRADS 0, 4-5) were included in our prospective study. All patients underwent bilateral HR DCE-MRI of the breast at 7 T (spatial resolution of 0.7 mm(3) voxel size, temporal resolution of 14 s). Two experienced readers (r1, r2) and one less experienced reader (r3) independently assessed lesions according to BI-RADS®. Image quality, lesion conspicuity and artefacts were graded from 1 to 5. Sensitivity, specificity and diagnostic accuracy were assessed using histopathology as the standard of reference. RESULTS: HR DCE-MRI at 7 T revealed 29 lesions in 23 patients (sensitivity 100 % (19/19); specificity of 90 % (9/10)) resulting in a diagnostic accuracy of 96.6 % (28/29) with an AUC of 0.95. Overall image quality was excellent in the majority of cases (27/29) and examinations were not hampered by artefacts. There was excellent inter-reader agreement for diagnosis and image quality parameters (κ = 0.89-1). CONCLUSION: Bilateral HR DCE-MRI of the breast at 7 T is feasible with excellent image quality in clinical practice and allows accurate breast cancer diagnosis. KEY POINTS: • Dynamic contrast-enhanced 7-T MRI is being developed in several centres. • Bilateral high resolution DCE-MRI of the breast at 7 T is clinically applicable. • 7-T HR DCE-MRI of the breast provides excellent image quality. • 7-T HR DCE-MRI should detect breast cancer with high diagnostic accuracy.

An optoacoustic imaging feature set to characterise blood vessels surrounding benign and malignant breast lesions.

Combining optoacoustic (OA) imaging with ultrasound (US) enables visualisation of functional blood vasculature in breast lesions by OA to be overlaid with the morphological information of US. Here, we develop a simple OA feature set to differentiate benign and malignant breast lesions. 94 female patients with benign, indeterminate or suspicious lesions were recruited and underwent OA-US. An OA-US imaging feature set was developed using images from the first 38 patients, which contained 14 malignant and 8 benign solid lesions. Two independent radiologists blindly scored the OA-US images of a further 56 patients, which included 31 malignant and 13 benign solid lesions, with a sensitivity of 96.8% and specificity of 84.6%. Our findings indicate that OA-US can reveal vascular patterns of breast lesions that indicate malignancy using a simple feature set based on single wavelength OA data, which is therefore amenable to application in low resource settings for breast cancer management.

Abdominal and Cardiac Evaluation with Sonography in Shock (ACES): an approach by emergency physicians for the use of ultrasound in patients with undifferentiated hypotension.

BACKGROUND: Non-traumatic undifferentiated hypotension is a common critical presentation in the emergency department. In this group of patients, early diagnosis and goal-directed therapy is essential for an optimal outcome. The usefulness of focused bedside ultrasound is reviewed and a protocol for Abdominal and Cardiac Evaluation with Sonography in Shock (ACES) is proposed. METHODS: The protocol consists of six windows including cardiac, peritoneal, pleural, inferior vena cava and aortic views, and aims to shorten the time period taken to establish a diagnosis and hence to deliver the most appropriate goal-directed therapy. Its use in seven case examples is described. RESULTS: In all cases the ACES protocol helped in guiding the initial management while further information was obtained. CONCLUSION: The six-view ACES protocol is a useful adjunct to clinical examination in patients with undifferentiated hypotension in the emergency department. A prospective randomised trial or multicentre database/registry is needed to investigate the validity and impact of this protocol on the early diagnosis and management of hypotensive patients.

The encephalopathic child.

Encephalopathy is a common paediatric emergency associated with a high risk of morbidity, mortality and long term neurodevelopmental delay in survivors. Prompt diagnosis of the cause of encephalopathy enables the paediatrician to deliver specific medical or surgical treatment that will facilitate a better short and long term outcome. Diagnostic imaging plays a pivotal role in diagnosis. Encephalopathy has many causes. The differential diagnosis includes non accidental injury, trauma, metabolic syndromes, meningo-encephalitis, toxins, hypoxia, demyelination, stroke, haemorrhage and tumours. We describe an approach that helps us formulate an imaging strategy using US, CT and MRI that facilitates patient care.

Anti-HPA-1a-mediated platelet phagocytosis by monocytes in vitro and its inhibition by Fc gamma receptor (FcgammaR) reactive reagents.

The study was undertaken to delineate mechanisms of platelet destruction by phagocytosis during fetal/neonatal alloimmune thrombocytopenia (FAIT/NAIT) because of maternal antibodies against human platelet antigen 1a (HPA-1a). By employing a platelet phagocytosis assay based on the ORPEGEN flow cytometric bacterial phagocytosis test, we measured monocyte ingestion of platelets mediated by anti-HPA-1a antibodies. Moreover, we tested, as potential therapeutic agents, FcgammaR reactive reagents, for their inhibition of this process. Four of six anti-HPA-1a sera tested mediated phagocytosis of HPA-1a-positive platelets in a concentration-dependent manner. Monocyte ingestion of platelets was almost completely inhibited by cytochalasin D. No anti-HPA-1a-mediated phagocytosis was observed with anti-HPA-1a-negative platelets. The humanised anti-FcgammaRI monoclonal antibody H22 at concentrations 1-100 microg/ml, completely inhibited anti-HPA-1a-mediated phagocytosis as did similar concentrations of ivIg. By contrast, a mouse monoclonal anti-FcgammaRII (IV.3, Fab) at 10 microg/ml caused little or no suppression of platelet phagocytosis mediated by two anti-HPA-1 sera. Furthermore, the addition of anti-FcgammaRII (10 microg/ml) to sub-optimal concentrations of H22 did not significantly increase the inhibitory effect of the latter compound. Monomeric IgG (0.1-10 microg/ml) failed to suppress anti-HPA-1 mediated platelet ingestion by the phagocytes, as did anti-FcgammaRIII. To our knowledge this is a rare example of an assay that measures platelet phagocytosis in vitro. The results suggest that FcgammaRI plays a major role in anti-HPA-1a-mediated platelet phagocytosis by monocytes while FcgammaRIIa, is of little or minor importance only. Moreover, the findings indicate the use of H22 as an alternative to interavenous Ig (ivIg) in the management of FAIT/NAIT.