Effectiveness of biomarker-based exclusion of ventilator-acquired pneumonia to reduce antibiotic use (VAPrapid-2): study protocol for a randomised controlled trial.

BACKGROUND: Ventilator-acquired pneumonia (VAP) is a common reason for antimicrobial therapy in the intensive care unit (ICU). Biomarker-based diagnostics could improve antimicrobial stewardship through rapid exclusion of VAP. Bronchoalveloar lavage (BAL) fluid biomarkers have previously been shown to allow the exclusion of VAP with high confidence. METHODS/DESIGN: This is a prospective, multi-centre, randomised, controlled trial to determine whether a rapid biomarker-based exclusion of VAP results in fewer antibiotics and improved antimicrobial management. Patients with clinically suspected VAP undergo BAL, and VAP is confirmed by growth of a potential pathogen at [≥] 10(4) colony-forming units per millilitre (CFU/ml). Patients are randomised 1:1, to either a 'biomarker-guided recommendation on antibiotics' in which BAL fluid is tested for IL-1ß and IL-8 in addition to routine microbiology testing, or to 'routine use of antibiotics' in which BAL undergoes routine microbiology testing only. Clinical teams are blinded to intervention until 6 hours after randomisation, when biomarker results are reported to the clinician. The primary outcome is a change in the frequency distribution of antibiotic-free days (AFD) in the 7 days following BAL. Secondary outcome measures include antibiotic use at 14 and 28 days; ventilator-free days; 28-day mortality and ICU mortality; sequential organ failure assessment (SOFA) at days 3, 7 and 14; duration of stay in critical care and the hospital; antibiotic-associated infections; and antibiotic-resistant pathogen cultures up to hospital discharge, death or 56 days. A healthcare-resource-utilisation analysis will be calculated from the duration of critical care and hospital stay. In addition, safety data will be collected with respect to performing BAL. A sample size of 210 will be required to detect a clinically significant shift in the distribution of AFD towards more patients having fewer antibiotics and therefore more AFD. DISCUSSION: This trial will test whether a rapid biomarker-based exclusion of VAP results in rapid discontinuation of antibiotics and therefore improves antibiotic management in patients with suspected VAP. TRIAL REGISTRATION: ISRCTN65937227 . Registered on 22 August 2013. ClinicalTrials.gov, NCT01972425 . Registered on 24 October 2013.

A randomised trial of a remote home support programme for infants with major congenital heart disease.

OBJECTIVES: To assess the sustainability, clinical utility and acceptability to clinicians and parents of a tele-homecare programme for infants with major congenital heart disease (CHD), and to evaluate the impact on healthcare resource use. DESIGN: Randomised control trial. SETTING: UK tertiary congenital cardiac centre. PARTICIPANTS: 83 infants with major CHD. INTERVENTION: Participants were randomised to one of three groups: video-conferencing support (n=35), telephone support (n=24) and a control group (n=24). Patients in the two intervention groups received regular, standardised remote consultations. Video-conferences (VCs) were facilitated by Integrated Systems Digital Network lines and replaced by home broadband connections later in the study. MAIN OUTCOME MEASURES: Healthcare resource use, utilisation including hospitalisation, clinicians' opinions on utility and quality of interventions, parental opinions on quality of interventions. RESULTS: Clinicians were more confident making medical decisions following VCs compared with telephone consultations (p=0.01). Both VC and telephone support were very well received, but parents expressed significantly higher levels of satisfaction with VC support (p=0.001). Healthcare resource use was 37% lower in the video-conferencing group compared with both telephone support and control groups (p<0.001), as was the risk of hospitalisation (p=0.006). Direct health service costs were significantly lower in the video-conferencing group (p<0.05). CONCLUSIONS: A tele-medicine home support programme for families of infants with major CHD is feasible, sustainable and effective. Home support with video-conferencing is superior to telephone consultations. Parents are highly satisfied with tele-homecare. Tele-homecare significantly reduces health service utilisation and may reduce health service costs.

Cost-utility analysis of a pharmacy-led self-management programme for patients with COPD.

OBJECTIVE: To undertake a cost-utility analysis (CUA) of a pharmacy-led self-management programme for Chronic Obstructive Pulmonary Disease (COPD). SETTING: A single outpatient COPD clinic at the Mater Hospital, Belfast, Northern Ireland between. METHOD: CUA alongside a randomised control trial. The economic analysis used data from 127 COPD patients aged over 45 years, with an FEV1 of 30-80% of the predicted normal value. Participants received either a pharmacy-led education and self-management programme, or usual care. One year costs were estimated from the perspective of the National Health Service and Personal Social Services and quality-adjusted life years (QALYs) were calculated based on responses to the EQ-5D at baseline, 6 and 12 months. MAIN OUTCOME MEASURE: Cost per QALY gained. RESULTS: The mean differences in costs and effects between the self-management and education programme and usual care were -£671.59 (95 CI%: -£1,584.73 to -£68.14) and 0.065 (95% CI; 0.000-0.128). Thus the intervention was the dominant strategy as it was both less costly and more effective than usual care. The probability of the intervention being cost-effective was 95% at a threshold of £20,000/QALY gained. Sensitivity analyses indicated that conclusions were robust to variations in most of the key parameters. CONCLUSION: The self-management and education programme was found to be highly cost-effective compared to usual care. Further research is required to establish what aspects of self-management and education programmes have the greatest impact on cost-effectiveness.