Effects of the Australian National Hand Hygiene Initiative after 8 years on infection control practices, health-care worker education, and clinical outcomes: a longitudinal study.

BACKGROUND: The National Hand Hygiene Initiative (NHHI) is a standardised culture-change programme based on the WHO My 5 Moments for Hand Hygiene approach to improve hand hygiene compliance among Australian health-care workers and reduce the risk of health-care-associated infections. We analysed its effectiveness. METHODS: In this longitudinal study, we assessed outcomes of the NHHI for the 8 years after implementation (between Jan 1, 2009, and June 30, 2017), including hospital participation, hand hygiene compliance (measured as the proportion of observed Moments) three times per year, educational engagement, cost, and association with the incidence of health-care-associated Staphylococcus aureus bacteraemia (HA-SAB). FINDINGS: Between 2009 and 2017, increases were observed in national health-care facility participation (105 hospitals [103 public and two private] in 2009 vs 937 hospitals [598 public and 339 private] in 2017) and overall hand hygiene compliance (36 213 [63·6%] of 56 978 Moments [95% CI 63·2-63·9] in 2009 vs 494 673 [84·3%] of 586 559 Moments [84·2-84·4] in 2017; p<0·0001). Compliance also increased for each Moment type and for each health-care worker occupational group, including for medical staff (4377 [50·5%] of 8669 Moments [95% CI 49·4-51·5] in 2009 vs 53 620 [71·7%] of 74 788 Moments [71·4-72·0]; p<0·0001). 1 989 713 NHHI online learning credential programmes were completed. The 2016 NHHI budget was equivalent to AUD$0·06 per inpatient admission nationally. Among Australia's major public hospitals (n=132), improved hand hygiene compliance was associated with declines in the incidence of HA-SAB (incidence rate ratio 0·85; 95% CI 0·79-0·93; p≤0·0001): for every 10% increase in hand hygiene compliance, the incidence of HA-SAB decreased by 15%. INTERPRETATION: The NHHI has been associated with significant sustained improvement in hand hygiene compliance and a decline in the incidence of HA-SAB. Key features include sustained central coordination of a standardised approach and incorporation into hospital accreditation standards. The NHHI could be emulated in other national culture-change programmes. FUNDING: Australian Commission on Safety and Quality in Health Care.

Pediatric drug information available at the time of new drug approvals: A cross-sectional analysis.

PURPOSE: Greater than 50% of drugs lack pediatric labeling information, resulting in widespread "off-label" use in children. To increase pediatric prescribing information, the Pediatric Research Equity Act (PREA) was passed in 2003, requiring new drug applications to include pediatric assessments. We evaluated the study of new drugs in children since PREA was implemented. METHODS: We performed a cross-sectional analysis of new drug applications submitted to the FDA from December 2003 to July 2012, using publicly available documents at Drugs@FDA. We calculated the proportion of new drugs that included a pediatric assessment at the time of approval and at a final review performed in July 2016. RESULTS: We identified 92 new drugs requiring pediatric assessments. Only 20 (21.7%) had been fully studied in children at the time of approval, while 9 (9.8%) had been partially assessed, and 63 (68.5%) did not have pediatric data. Among drugs approved without pediatric assessments, 4.2% met FDA deferral deadlines and 34.9% eventually submitted pediatric data. At the time of our final review, allowing for a mean of 8.6 years since drug approval, 57.6% of new drugs had not been fully assessed in children. The mean time between approval in adults and availability of pediatric data for drugs approved without pediatric assessments was 6.5 years. CONCLUSIONS: These results represent a comprehensive evaluation of the study of new drugs in children and demonstrate that many drugs continue to be approved without pediatric data. Our findings serve to inform approaches to strengthen adherence to PREA requirements.

Diagnosing swine flu: the inaccuracy of case definitions during the 2009 pandemic, an attempt at refinement, and the implications for future planning.

BACKGROUND: At the onset of the pandemic H1N1/09 influenza A outbreak in Australia, health authorities devised official clinical case definitions to guide testing and access to antiviral therapy. OBJECTIVES: To assess the diagnostic accuracy of these case definitions and to attempt to improve on them using a scoring system based on clinical findings at presentation. PATIENTS/METHODS: This study is a retrospective case-control study across three metropolitan Melbourne hospitals and one associated community-based clinic during the influenza season, 2009. Patients presenting with influenza-like illness who were tested for H1N1/09 influenza A were administered a standard questionnaire of symptomatology, comorbidities, and risk factors. Patients with a positive test were compared to those with a negative test. Logistic regression was performed to examine for correlation of clinical features with disease. A scoring system was devised and compared with case definitions used during the pandemic. The main outcome measures were the positive and negative predictive values of our scoring system, based on real-life data, versus the mandated case definitions'. RESULTS: Both the devised scoring system and the case definitions gave similar positive predictive values (38-58% using ascending score groups, against 39-44% using the various case definitions). Negative predictive values were also closely matched (ranging from 94% to 73% in the respective score groups against 83-84% for the case definitions). CONCLUSIONS: Accurate clinical diagnosis of H1N1/09 influenza A was difficult and not improved significantly by a structured scoring system. Investment in more widespread availability of rapid and sensitive diagnostic tests should be considered in future pandemic planning.