Diagnostic and economic evaluation of a point-of-care test for respiratory syncytial virus.

Respiratory syncytial virus is a common cause of bronchiolitis. Historically, point-of-care tests have involved antigen detection technology with limited sensitivity. The aim of this study was to prospectively evaluate the diagnostic accuracy and model the economic impact of the Roche cobas® Liat® point-of-care influenza A/B and respiratory syncytial virus test. The "DEC-RSV" study was a multi-centre, prospective, observational study in children under 2 years presenting with viral respiratory symptoms. A nasopharyngeal aspirate sample was tested using the point-of-care test and standard laboratory-based procedures. The primary outcome was accuracy of respiratory syncytial virus detection. The cost implications of adopting a point-of-care test were modelled using study data. A total of 186 participants were recruited, with both tests performed on 177 samples. The point-of-care test was invalid for 16 samples (diagnostic yield 91%) leaving 161 available for primary analysis. After resolving discrepancies, the cobas® Liat® respiratory syncytial virus test had 100.00% (95% CI 96.07%-100.00%) sensitivity and 98.53% (95% CI 92.08%-99.96%) specificity. Median time to result was 0.6 h (interquartile range (IQR) 0.5-1) for point-of-care testing and 28.9 h (IQR 26.3-48.1) for standard laboratory testing. Estimated non-diagnostic cost savings for 1000 patients, based on isolation decision-making on point-of-care test result, were £57 010, which would increase to £94 847 when cohort nursing is used. In young children the cobas® Liat® point-of-care respiratory syncytial virus test has high diagnostic accuracy using nasopharyngeal aspirates (currently an off-licence sample type). Time to result is clinically important and was favourable compared to laboratory-based testing. The potential exists for cost savings when adopting the point-of-care test.

Parental decisions on children participating in research.

AIM: To observe and report rates of, and reasons for, parents' refusal to consent to the participation of their children in appropriate clinical research. METHODS: The parents of children admitted to hospital with a diagnosis of pneumonia or of empyema were asked for informed consent to research involving blood, urine and nasopharyngeal secretion samples from their child. Circumstances and numbers of agreements and refusals were compared and underlying reasons suggested. RESULTS: Of 144 consent requests, ten were refused, which appeared to be linked to: not wanting the child to undergo further tests, lack of interest in participating in studies, research possibly delaying discharge, and anxiety regarding written consent and the length of information sheets. CONCLUSIONS: Severity of the child's illness appeared to determine the parent's decision. Involvement and assistance of non-research nursing and medical staff and previous introductions to the researchers are helpful. The timing and setting for the consent process should be selected carefully. Adequate, accessible study information for parents and children contributes to successful recruitment of participants.

Emergence of pneumococcal 19A empyema in UK children.

INTRODUCTION: Invasive pneumococcal disease due to serotype 19A has become a major concern, particularly in the USA and Asia. We describe the characteristics of pneumococcal serotype 19A related empyema and changes in its incidence in the UK. METHODS: Data from paediatric empyema patients between September 2006 and March 2011 were collected from 17 respiratory centres in the UK. Pneumococcal serotypes were identified as part of the Health Protection Agency enhanced paediatric empyema surveillance programme. RESULTS: Four serotypes accounted for over 80% of 136 cases (Serotype 1 : 43%, 3 : 21%, 7 : 11% and 19A:10%). The incidence of empyema due to serotype 19A quadrupled from 0.48 (0.16-1.13) cases per million children in 2006/2007 to 2.02 (1.25-3.09) in 2010/2011. Severity of disease was significantly increased in children with 19A infection when compared to other serotypes. CONCLUSIONS: The incidence of empyema due to pneumococcal serotype 19A infection has increased significantly and is associated with substantial morbidity.