Implementing a strategic plan for research.

Effective integration of research within healthcare organisations is recognised to improve outcomes. A research strategy within a hospital Trust in South West England was revised, following the launch of a national Chief Nursing Officer (CNO) strategy that promotes research engagement and activity. The aim was to develop, implement and evaluate this revised strategic plan for research. High-level engagement within the organisation was established and previous initiatives evaluated. A 6-year plan with 2-year targets was defined and evaluated at year end. The four pillars of the CNO strategy were central to the revised strategy, underpinned by digital innovation. Evaluation of the earlier strategy indicated excellent engagement with the Chief Nurse Research Fellow initiative and the Clinical Academic Network. The 'Embedding Research In Care' (ERIC) unit was reconfigured to an ERIC model, which aided question generation and project development. Year one objectives were achieved within the revised plan. Implementing a research strategy within an organisation requires a cultural shift and a long-term vision is required with measurable objectives. The team demonstrated significant progress through high-level leadership, mentoring and cross-professional collaboration.

The short term safety of COVID-19 vaccines in Australia: AusVaxSafety active surveillance, February - August 2021.

OBJECTIVE: To assess the short term safety of the COVID-19 vaccines Comirnaty (Pfizer-BioNTech BNT162b2) and Vaxzevria (AstraZeneca ChAdOx1) in Australia. DESIGN: Prospective observational cohort study; online surveys by AusVaxSafety, a national active vaccine safety surveillance system, three and eight days after vaccination. SETTING, PARTICIPANTS: People aged 16 years or more who received COVID-19 vaccines at sentinel vaccination hubs, general practices, or Aboriginal Community Controlled Health Organisation clinics, 22 February - 30 August 2021. MAIN OUTCOME MEASURES: Primary outcome: proportion of respondents who reported any adverse event following immunisation (AEFI) 0-3 days after vaccination. SECONDARY OUTCOMES: proportions of respondents who reported specific adverse events or medical review for AEFI within seven days of vaccination; impact on usual daily activities; recovery. RESULTS: 4 851 480 people received COVID-19 vaccines at participating sentinel sites during the study period (25% of all COVID-19 vaccine doses administered in Australia to 30 August 2021). 3 035 983 people responded to both surveys (response rate, 62.6%); 35.9% of respondents reported one or more AEFI 0-3 days after Comirnaty dose 1, 54.7% after Comirnaty dose 2, 52.8% after Vaxzevria dose 1, and 22.0% after Vaxzevria dose 2. Local pain, fatigue, headache, and myalgia were the most frequently reported symptoms. After adjusting for demographic characteristics, vaccination site type, jurisdiction, and self-reported medical conditions, the odds of reporting any AEFI were higher for women than men (range of adjusted odd ratios [aORs], by vaccine and dose, 1.53-1.84), for people with a history of anaphylaxis (aOR range, 1.28-1.45), and for people reporting certain underlying conditions, including obesity (aOR range, 1.15-1.75), immunodeficiency (aOR range, 1.04-2.24), or chronic inflammatory disease (aOR range, 1.05-1.75). 0.9% of respondents sought medical advice in the three days following vaccination, most frequently after Comirnaty dose 2 (1.4%) and Vaxzevria dose 1 (1.2%). CONCLUSION: AusVaxSafety active surveillance affirms the short term safety profile of Comirnaty and Vaxzevria vaccines in a large population sample during the first six months of the Australian COVID-19 vaccination program.

Risk factors and disease severity in Australian infants aged under 6 months hospitalised with influenza 2011-2019.

AIM: Infants aged <6 months are vulnerable to severe influenza disease and no vaccine is approved for use in this age group. We aimed to describe the epidemiology, risk factors associated with severe outcomes and management of influenza in Australian infants aged <6 months. METHODS: Incident cases aged <6 months of laboratory-confirmed influenza were captured through two national active prospective sentinel hospital-based surveillance systems in Australia from 2011 to 2019, inclusive. Demographic and clinical features, disease risk factors and outcomes (intensive care unit (ICU) admission and length of stay) and oseltamivir use were analysed. The proportion of infant influenza hospitalisations and nosocomial cases among all hospitalisations were also reported. RESULTS: Of 680 hospitalised infants aged <6 months, 57.9% were male and 14.5% were Indigenous Australian. Median age was 2.6 months, 19.2% were born premature and 19.0% had a comorbidity, excluding prematurity. Overall, 77.9% had influenza A. Nosocomial cases accounted for 7.8%. ICU admission occurred in 14.7% and oseltamivir was prescribed for 18.8%. Factors associated with ICU admission included age <1 month (adjusted odds ratio (aOR) 3.95, 95% confidence interval (CI): 1.47-10.60), comorbidity (aOR 7.69, 95% CI: 4.04-14.64) and prematurity (aOR 2.60, 95% CI: 1.40-4.81). The proportion of infants with influenza among all infant hospitalisations ranged 1.0-2.6% in the 2019 influenza season. CONCLUSION: Infants aged <6 months, and particularly neonates, experience serious disease from influenza. This data underpins the need for preventative strategies such as maternal immunisation and continued investigation into the possibility of safe and efficacious vaccination prior to 6 months of age.

Seroprevalence of SARS-CoV-2-specific antibodies in Sydney after the first epidemic wave of 2020.

OBJECTIVES: To estimate SARS-CoV-2-specific antibody seroprevalence after the first epidemic wave of coronavirus disease 2019 (COVID-19) in Sydney. SETTING, PARTICIPANTS: People of any age who had provided blood for testing at selected diagnostic pathology services (general pathology); pregnant women aged 20-39 years who had received routine antenatal screening; and Australian Red Cross Lifeblood plasmapheresis donors aged 20-69 years. DESIGN: Cross-sectional study; testing of de-identified residual blood specimens collected during 20 April - 2 June 2020. MAIN OUTCOME MEASURE: Estimated proportions of people seropositive for anti-SARS-CoV-2-specific IgG, adjusted for test sensitivity and specificity. RESULTS: Thirty-eight of 5339 specimens were IgG-positive (general pathology, 19 of 3231; antenatal screening, 7 of 560; plasmapheresis donors, 12 of 1548); there were no clear patterns by age group, sex, or location of residence. Adjusted estimated seroprevalence among people who had had general pathology blood tests (all ages) was 0.15% (95% credible interval [CrI], 0.04-0.41%), and 0.29% (95% CrI, 0.04-0.75%) for plasmapheresis donors (20-69 years). Among 20-39-year-old people, the age group common to all three collection groups, adjusted estimated seroprevalence was 0.24% (95% CrI, 0.04-0.80%) for the general pathology group, 0.79% (95% CrI, 0.04-1.88%) for the antenatal screening group, and 0.69% (95% CrI, 0.04-1.59%) for plasmapheresis donors. CONCLUSIONS: Estimated SARS-CoV-2 seroprevalence was below 1%, indicating that community transmission was low during the first COVID-19 epidemic wave in Sydney. These findings suggest that early control of the spread of COVID-19 was successful, but efforts to reduce further transmission remain important.

Barriers to influenza vaccination of children hospitalised for acute respiratory illness: A cross-sectional survey.

AIM: To identify barriers to influenza vaccination of children hospitalised for acute respiratory illness in Australia. METHODS: A total of 595 parents of children hospitalised with acute respiratory illness across five tertiary hospitals in 2019 participated in an online survey. Multivariate logistic regression identified factors most strongly associated with influenza vaccination barriers. RESULTS: Odds of influenza vaccination were lower with lack of health-care provider (HCP) recommendation (adjusted odds ratio (aOR) 0.18; 95% confidence interval (CI): 0.08-0.38); if parents had difficulties (aOR 0.19; 95% CI: 0.08-0.47) or were 'neutral' (aOR 0.23; 95% CI: 0.06-0.82) in remembering to make an appointment; and if parents had difficulties (aOR 0.21; 95% CI: 0.07-0.62) or were 'neutral' (aOR 0.24; 95% CI: 0.07-0.79) regarding getting an appointment for vaccination. Odds were also lower if parents did not believe (aOR 0.27; 95% CI: 0.08-0.90) or were 'neutral' (aOR 0.15; 95% CI: 0.04-0.49) regarding whether the people most important to them would have their child/ren vaccinated against influenza. Children had lower odds of vaccination if parents did not support (aOR 0.09; 95% CI: 0.01-0.82) or were ambivalent (aOR 0.09; 95% CI: 0.01-0.56) in their support for influenza vaccination. Finally, lack of history of influenza vaccination of child (aOR 0.38; 95% CI: 0.18-0.81) and respondent (aOR 0.25; 95% CI: 0.11-0.56) were associated with lack of receipt of influenza vaccine before admission for acute respiratory infection. CONCLUSIONS: Assisting parents in remembering and accessing influenza vaccination and encouraging health-care providers to recommend vaccination may increase uptake.

Effectiveness of Acellular Pertussis Vaccine in Older Adults: Nested Matched Case-control Study.

BACKGROUND: Despite recommendations that older adults receive acellular pertussis vaccines, data on direct effectiveness in adults aged over 50 years are sparse. METHODS: A case-control study nested within an adult cohort. Cases were identified from linked pertussis notifications and each matched to 3 controls on age, sex, and cohort recruitment date. Cases and controls were invited to complete a questionnaire, with verification of vaccination status by their primary care provider. Vaccine effectiveness (VE) was estimated by conditional logistic regression, with adjustment for reported contact with children and area of residence. RESULTS: Of 1112 notified cases in the cohort, we had complete data for 333 cases and 506 controls. Among 172 PCR-diagnosed cases (mean age, 61 years), 11.2% versus 19.5% of controls had provider-verified pertussis vaccination, on average, 3.2 years earlier. Adjusted VE against PCR-diagnosed pertussis was 52% (95% CI, 15-73%), nonsignificantly higher if vaccinated within 2 years (63%; -5-87%). Adjusted VE was similar in adults born before 1950, presumed primed by natural infection (51%; -8-77%) versus those born 1950 or later who may have received whole-cell pertussis vaccine (53%; -11-80%) (P-heterogeneity = 0.9). Among 156 cases identified by single-point serology, adjusted VE was -55% (-177-13%). CONCLUSIONS: We found modest protection against PCR-confirmed pertussis among older adults (mean age, 61 years; range, 46-81 years) within 5 years after acellular vaccine. The most likely explanation for the markedly divergent VE estimate from cases identified by single-titer serology is misclassification arising from limited diagnostic specificity in our setting.

Severe and Complicated Varicella and Associated Genotypes 10 Years After Introduction of a One-Dose Varicella Vaccine Program.

Background: This national, sentinel prospective study aimed to identify children with severe hospitalized varicella, despite availability of universal 1-dose vaccination since 2005, and determine associations between virus genotypes and disease severity. Methods: Children with varicella or zoster from 5 Paediatric Active Enhanced Disease Surveillance hospitals were enrolled. Lesions were swabbed for genotyping. Associations with disease severity were analyzed using multiple regression. Results: From 2007 to 2015, 327 children with confirmed varicella (n = 238) or zoster (n = 89) were enrolled. Two hundred three (62%) were immunocompetent children; including 5 of 8 children who required intensive care unit management. Eighteen percent (36 of 203) of immunocompetent children had been previously vaccinated. Vaccinated children aged >18 months were less likely to have severe disease (9%; 5 of 56) than unvaccinated children (21%; 21 of 100; P = .05). Three of 126 children who had virus genotyping (2 immunocompromised) had varicella (n = 2) or zoster (n = 2) due to the Oka/vaccine strain. European origin clades predominated and were independently associated with more severe disease (odds ratio = 3.2; 95% confidence interval, 1.1- 9.5; P = .04). Conclusions: Severe hospitalized varicella still occurs with a 1-dose varicella program, although predominantly in unvaccinated children. Most 1-dose vaccine recipients were protected against severe disease. Viral genotyping in complex hospitalized cases is important to assist in monitoring disease due to Oka-vaccine strain.

Social norm feedback reduces primary care antibiotic prescribing in a regression discontinuity study.

BACKGROUND: Reducing antibiotic prescribing is a priority for health authorities responsible for preventing antimicrobial resistance. Northern Ireland has high rates of antimicrobial use. We implemented a social norm feedback intervention and evaluated its impact. OBJECTIVES: To estimate the size and duration of the effect of a social norm feedback letter to GPs who worked in the 20% of practices with the highest antimicrobial prescribing. METHODS: The letter was sent in October 2017 to 221 GPs in 67 practices. To assess the effect of the intervention, we used a sharp non-parametric regression discontinuity (RD) design, with prescribing rates in the four calendar quarters following the intervention as the outcome variables. RESULTS: In the quarter following the intervention (October to December 2017) there was a change of -25.7 (95% CI = -42.5 to -8.8, P = 0.0028) antibiotic items per 1000 Specific Therapeutic group Age-sex Related Prescribing Units (STAR-PU). At 1 year, the coefficient was -58.7 (95% CI = -116.7 to -0.7, P = 0.047) antibiotic items per 1000 STAR-PU. The greatest change occurred soon after the intervention. Approximately 18900 fewer antibiotic items were prescribed than if the intervention had not been made (1% of Northern Ireland's annual primary care antibiotic prescribing). CONCLUSIONS: A social norm feedback intervention reduced antibiotic prescribing in the intervention practices. The diminishing effect over time suggests the need for more frequent feedback. The RD method allowed measurement of the effectiveness of an intervention that was delivered as part of normal business, without a randomized trial.

Effectiveness of 7- and 13-Valent Pneumococcal Conjugate Vaccines in a Schedule Without a Booster Dose: A 10-Year Observational Study.

Background: Unique among high-income countries, Australia has used a 3 + 0 schedule (3 primary doses, no booster) for infant pneumococcal conjugate vaccine (PCV) since January 2005, initially 7 valent (PCV7) then 13 valent (PCV13) from July 2011. We measured vaccine effectiveness (VE) of both PCVs against invasive pneumococcal disease (IPD) using 2 methods. Methods: Cases were IPD notifications to the national surveillance system of children eligible for respective PCVs. For case-control method, up to 10 age-matched controls were derived from the Australian Childhood Immunisation Register. For indirect cohort method, controls were IPD cases due to serotypes not in PCVs. VE was calculated as (1 - odds ratio [OR]) × 100 by logistic regression. VE waning was estimated as odds of vaccine type (VT) IPD in consecutive 12-month periods post-dose 3. Results: Between 2005 and 2014, there were 1209 and 308 IPD cases in PCV7-eligible and PCV13-eligible cohorts, respectively. Both methods gave comparable VE estimates. In infants, VE for 3 doses against VT IPD was 92.9% (95% confidence interval [CI], 27.7% to 99.3%) for PCV7 and 86.5% (95% CI, 11.7% to 97.9%) for PCV13. From 12 months post-dose 3, the odds of VT IPD by 24-36 months increased significantly for PCV7 (5.6, 95% CI, 1.2-25.4) and PCV13 (5.9, 95% CI, 1.0-35.2). Conclusions: For both PCVs in a 3 + 0 schedule, despite similar VE, progressive increase in breakthrough cases only occurred post-PCV13. This supports the importance of a booster dose of PCV13 in the second year of life to maintain protection.

Population-Level Herd Protection of Males From a Female Human Papillomavirus Vaccination Program: Evidence from Australian Serosurveillance.

BACKGROUND: Australia instituted funded female human papillomavirus (HPV) immunization in 2007, followed by a targeted male vaccination program in 2013. To date, Australia is one of only several countries with a funded male HPV immunization program. In 2012-2013, we conducted a survey of HPV seroprevalence in males to assess whether or not a herd impact of female vaccination could be observed. METHODS: We conducted a cross-sectional study of de-identified residual diagnostic test serum samples from males aged 15-39 years from laboratories in 3 Australian states and calculated the proportion seropositive to HPV types 6, 11, 16, and 18. We compared type-specific results by age group against those from a baseline 2005 Australian HPV serosurvey. RESULTS: There were decreases in proportion seropositive for every HPV type across all age groups, many statistically significant. The largest decrease was observed for HPV-11, with decreases of 8- and 9-fold for ages 20-29 and 30-39 years, respectively. Despite substantial reductions in seroprevalence, at least 9% of males were seropositive for at least 1 of the 4 HPV types. CONCLUSIONS: This is the first serosurvey confirming broad population-level impact in males from female HPV vaccination. Our research may assist policy makers considering implementing HPV vaccination programs.

Surveillance of adverse events following immunisation in Australia, 2015.

This report summarises Australian passive surveillance data for adverse events following immunisation (AEFI) for 2015 reported to the Therapeutic Goods Administration and compares them to long-term trends. There were 2,924 AEFI records for vaccines administered in 2015; an annual AEFI reporting rate of 12.3 per 100,000 population. There was a decline of 7% in the overall AEFI reporting rate in 2015 compared with 2014. This decline in reported adverse events in 2015 compared to the previous year was mainly attributable to fewer reports following the HPV vaccine and replacement of monovalent vaccines (Hib, MenCCV and varicella) with combination vaccines such as Hib-MenC, and MMRV. AEFI reporting rates for most individual vaccines were lower in 2015 compared with 2014. The most commonly reported reactions were injection site reaction (26%), pyrexia (17%), rash (16%), vomiting (8%) and headache (7%). The majority of AEFI reports (85%) were described as non-serious events. There were two deaths reported, but no clear causal relationship with vaccination was found.

Paediatric Active Enhanced Disease Surveillance (PAEDS) annual report 2015: Prospective hospital-based surveillance for serious paediatric conditions.

INTRODUCTION: The Paediatric Active Enhanced Disease Surveillance (PAEDS) network is a hospital-based active surveillance system employing prospective case ascertainment for selected serious childhood conditions, particularly vaccine preventable diseases and potential adverse events following immunisation (AEFI). PAEDS data is used to better understand these conditions, inform policy and practice under the National Immunisation Program, and enable rapid public health responses for certain conditions of public health importance. PAEDS enhances data available from other Australian surveillance systems by providing prospective, detailed clinical and laboratory information on children with selected conditions. This is the second of the planned annual PAEDS reporting series, and presents surveillance data for 2015. METHODS: Specialist surveillance nurses screened hospital admissions, emergency department records, laboratory and other data, on a daily basis in 5 paediatric tertiary referral hospitals in New South Wales, Victoria, South Australia, Western Australia and Queensland to identify children with the selected conditions. Standardised protocols and case definitions were used across all sites. Conditions under surveillance in 2015 included acute flaccid paralysis (a syndrome associated with poliovirus infection), acute childhood encephalitis (ACE), influenza, intussusception (IS; a potential AEFI with rotavirus vaccines), pertussis and varicella-zoster virus infection (varicella and herpes zoster). Most protocols restrict eligibility to hospitalisations, ED only presentations are also included for some conditions. METHODS: : In 2015, there were 674 cases identified across all conditions under surveillance. Key outcomes of PAEDS included: contribution to national AFP surveillance to reach WHO reporting targets; identification of signals for Mycoplasma pneumoniae and parechovirus-related outbreaks (ACE surveillance); and demonstration of high influenza activity with vaccine effectiveness (VE) analysis supportive of vaccination. Surveillance for IS remains ongoing with any identified AEFIs reported to the relevant State Health Department; varicella and herpes zoster case numbers decreased slightly from previous years in older children not eligible for catch-up. Pertussis case numbers increased in early 2015 and analysis of cases in children aged <1 year demonstrated the importance of timely childhood and maternal immunisation. CONCLUSIONS: PAEDS continues to provide unique policy-relevant data on serious paediatric conditions using hospital-based sentinel surveillance.

Changing Patterns of Pertussis in a Children's Hospital in the Polymerase Chain Reaction Diagnostic Era.

OBJECTIVE: To assess changes in diagnostic practice and vaccine schedules for pertussis, we used culture-confirmation and clinical severity to compare pertussis cases at a single Australian tertiary pediatric hospital during relevant periods. STUDY DESIGN: We replicated the case ascertainment methods of a study reporting a 2-year epidemic period 1997-1999 (whole cell pertussis vaccine with 18-month booster, only culture available) to conduct a retrospective cross-sectional observational study over a 6-year period 2007-2012 (acellular pertussis vaccine, no 18-month booster, polymerase chain reaction and culture available). Cases were compared from case note review 2007-2012 (including prevalence of comorbidities) and published data 1997-1999. RESULTS: During 2007-2012, average annual hospitalizations in those aged < 6 months increased 2.3-fold (32.0 vs 14.0) and in those aged > 6 months by 5.1-fold (17.7 vs 3.5). Limited to culture-positive hospitalizations, there was no increase in those aged < 6 months (14.0 vs 14.5) contrasted with a 4.6-fold increase in those aged > 6 months (2.3 vs 0.5), despite increased annual culture requests (488 vs 188). In 2007-2012, significant comorbidities were documented in 41/72 (57%) hospitalized children aged ≥ 12 months vs 38/225 (17%) <12 months (OR 6.5, 95% CI 3.7-11.7). CONCLUSIONS: Increased cases of culture-positive hospitalized pertussis were limited to fully immunized children > 6 months of age, consistent with schedule changes. Significant comorbidities were common, making a booster dose at 12-18 months of age especially important.

The Use of a Pressure-Indicating Sensor Film to Provide Feedback upon Hydrogel-Forming Microneedle Array Self-Application In Vivo.

PURPOSE: To evaluate the combination of a pressure-indicating sensor film with hydrogel-forming microneedle arrays, as a method of feedback to confirm MN insertion in vivo. METHODS: Pilot in vitro insertion studies were conducted using a Texture Analyser to insert MN arrays, coupled with a pressure-indicating sensor film, at varying forces into excised neonatal porcine skin. In vivo studies involved twenty human volunteers, who self-applied two hydrogel-forming MN arrays, one with a pressure-indicating sensor film incorporated and one without. Optical coherence tomography was employed to measure the resulting penetration depth and colorimetric analysis to investigate the associated colour change of the pressure-indicating sensor film. RESULTS: Microneedle insertion was achieved in vitro at three different forces, demonstrating the colour change of the pressure-indicating sensor film upon application of increasing pressure. When self-applied in vivo, there was no significant difference in the microneedle penetration depth resulting from each type of array, with a mean depth of 237 µm recorded. When the pressure-indicating sensor film was present, a colour change occurred upon each application, providing evidence of insertion. CONCLUSIONS: For the first time, this study shows how the incorporation of a simple, low-cost pressure-indicating sensor film can indicate microneedle insertion in vitro and in vivo, providing visual feedback to assure the user of correct application. Such a strategy may enhance usability of a microneedle device and, hence, assist in the future translation of the technology to widespread clinical use.

Surveillance of adverse events following immunisation in Australia annual report, 2014.

This report summarises Australian passive surveillance data for adverse events following immunisation (AEFI) for 2014 reported to the Therapeutic Goods Administration for 2014 and describes reporting trends over the 15-year period 1 January 2000 to 31 December 2014. There were 3,087 AEFI records for vaccines administered in 2014; an annual AEFI reporting rate of 13.2 per 100,000 population. There was a decline of 5% in the overall AEFI reporting rate in 2014 compared with 2013. This decline in reported adverse events in 2014 compared with the previous year was mainly attributable to fewer reports following the human papillomavirus (HPV) vaccine as it was the 2nd year of the extension of the National HPV Vaccination Program to males. AEFI reporting rates for most vaccines were lower in 2014 compared with 2013. The most commonly reported reactions were injection site reaction (27%), pyrexia (18%), rash (16%), vomiting (9%), headache (7%), and syncope (5%). The majority of AEFI reports described non-serious events while 7% (n=211) were classified as serious. There were 5 deaths reported with no clear causal relationship with vaccination found.

Paediatric Active Enhanced Disease Surveillance inaugural annual report, 2014.

INTRODUCTION: The Paediatric Active Enhanced Disease Surveillance (PAEDS) network is a hospital-based active surveillance system employing prospective case ascertainment of selected uncommon vaccine preventable diseases and potential adverse events following immunisation (AEFI). PAEDS enhances other Australian surveillance systems by providing prospective detailed clinical and laboratory data for the same child. METHODS: Specialist surveillance nurses screen hospital admissions, emergency department records, laboratory and other data, to prospectively identify hospitalised children aged under 15 years in 5 paediatric tertiary referral hospitals in New South Wales, Victoria, South Australia, Western Australia and Queensland. Standardised protocols and case definitions are used across all sites. Conditions under surveillance include vaccine preventable diseases: acute flaccid paralysis, varicella, pandemic and seasonal influenza and pertussis, and potential AEFIs: febrile seizures and intussusception. PAEDS also conducts surveillance for acute childhood encephalitis. RESULTS: Since August 2007, PAEDS has recruited a total of 6,227 hospitalised cases in total, for all conditions. From January to December 2014, there were 1,220 cases recruited across all conditions. Key outcomes include: enhanced acute flaccid paralysis surveillance to reach World Health Organization targets; supporting varicella and influenza vaccination in children; confirmation of a known low risk of febrile seizures following the 1st dose of measles-mumps-rubella vaccine but no increased risk of febrile seizures after measles-mumps-rubella-varicella vaccine, and a slightly increased risk of developing intussusception 1-7 days after rotavirus vaccination in infants aged less than 3 months. Acute childhood encephalitis data facilitated rapid investigation and response to the enterovirus 71 outbreak in 2013-2014. CONCLUSIONS: PAEDS provides unique policy-relevant data. This is the first of planned PAEDS annual reports to Communicable Diseases Intelligence.

Evaluating the implementation of the 13-valent pneumococcal vaccine supplementary dose program in Australian primary health care settings.

BACKGROUND: The availability of new pneumococcal conjugate vaccines covering a broader range of serotypes, has seen many countries introduce these into their national immunisation program. When transitioning from 7-valent to 13-valent pneumococcal conjugate vaccines, Australia is one of a small number of countries that included a supplementary dose of the 13-valent pneumococcal conjugate vaccine to offer protection against additional serotypes to an expanded age group of children. An evaluation of the implementation and uptake of the 13-valent pneumococcal conjugate vaccine supplementary dose was undertaken in two local health districts (LHDs) in New South Wales, Australia. METHODS: A self-administered postal survey of immunisation providers in the Northern New South Wales and Mid North Coast LHDs. Trends in vaccine ordering were examined. Coverage was assessed using data from the Australian Childhood Immunisation Register (ACIR). RESULTS: Of the 177 surveys sent, 125 were returned (70%). Almost all providers (96%) were aware of the 13vPCV supplementary dose program though took an opportunistic approach to program promotion and parental reminders. Supplementary doses of 13vPCV were ordered for 37% of the eligible cohort, mostly in the program's first six months. Coverage as recorded on the ACIR was 27%, though was lower in older children and those not due for scheduled childhood vaccines. Of the children who received the 13vPCV supplementary dose, 3% received it at the same time as vaccines due at 12-months of age, and 44% at the time of those due at 18-months of age. CONCLUSION: Despite the high awareness of the program, reported coverage was lower than that for other PCV supplementary dose programs in Australia and internationally. This may be influenced by providers' largely opportunistic approach to implementation, under-reporting to the ACIR or vaccine uptake. Lessons learned from this evaluation are relevant for future time-limited childhood vaccination programs. Prior to commencement, providers should be informed about the importance of catch-up/supplementary vaccination for their patients and their active role in promoting this. They should also receive program information before parents. An understanding of parental reasons for non-receipt of time-limited childhood vaccines and evaluation of the effect of aligning supplementary (or catch up) vaccination programs with the NIP schedule would be useful to inform future programs.

The outcome and cost-effectiveness of nurse-led care in people with rheumatoid arthritis: a multicentre randomised controlled trial.

OBJECTIVE: To determine the clinical effectiveness and cost-effectiveness of nurse-led care (NLC) for people with rheumatoid arthritis (RA). METHODS: In a multicentre pragmatic randomised controlled trial, the assessment of clinical effects followed a non-inferiority design, while patient satisfaction and cost assessments followed a superiority design. Participants were 181 adults with RA randomly assigned to either NLC or rheumatologist-led care (RLC), both arms carrying out their normal practice. The primary outcome was the disease activity score (DAS28) assessed at baseline, weeks 13, 26, 39 and 52; the non-inferiority margin being DAS28 change of 0.6. Mean differences between the groups were estimated controlling for covariates following per-protocol (PP) and intention-to-treat (ITT) strategies. The economic evaluation (NHS and healthcare perspectives) estimated cost relative to change in DAS28 and quality-adjusted life-years (QALY) derived from EQ5D. RESULTS: Demographics and baseline characteristics of patients under NLC (n=91) were comparable to those under RLC (n=90). Overall baseline-adjusted difference in DAS28 mean change (95% CI) for RLC minus NLC was -0.31 (-0.63 to 0.02) for PP and -0.15 (-0.45 to 0.14) for ITT analyses. Mean difference in healthcare cost (RLC minus NLC) was £710 (-£352, £1773) and -£128 (-£1263, £1006) for PP and ITT analyses, respectively. NLC was more cost-effective with respect to cost and DAS28, but not in relation to QALY utility scores. In all secondary outcomes, significance was met for non-inferiority of NLC. NLC had higher 'general satisfaction' scores than RLC in week 26. CONCLUSIONS: The results provide robust evidence to support non-inferiority of NLC in the management of RA. TRIAL REGISTRATION: ISRCTN29803766.