scholarly journals Vaccine effectiveness of live attenuated and trivalent inactivated influenza vaccination in 2010/11 to 2015/16: the SIVE II record linkage study

2020 ◽  
Vol 24 (67) ◽  
pp. 1-66
Author(s):  
Colin R Simpson ◽  
Nazir I Lone ◽  
Kim Kavanagh ◽  
Tanya Englishby ◽  
Chris Robertson ◽  
...  
Keyword(s):  
Adverse Events ◽  
Influenza Vaccine ◽  
Influenza Vaccination ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Health Technology ◽  
Vaccine Effectiveness ◽  
Rt Pcr ◽  
Trivalent Influenza Vaccine ◽  
The Uk

Background There is good evidence of vaccine effectiveness in healthy individuals but less robust evidence for vaccine effectiveness in the populations targeted for influenza vaccination. The live attenuated influenza vaccine (LAIV) has recently been recommended for children in the UK. The trivalent influenza vaccine (TIV) is recommended for all people aged ≥ 65 years and for those aged < 65 years who are at an increased risk of complications from influenza infection (e.g. people with asthma). Objective To examine the vaccine effectiveness of LAIV and TIV. Design Cohort study and test-negative designs to estimate vaccine effectiveness. A self-case series study to ascertain adverse events associated with vaccination. Setting A national linkage of patient-level general practice (GP) data from 230 Scottish GPs to the Scottish Immunisation & Recall Service, Health Protection Scotland virology database, admissions to Scottish hospitals and the Scottish death register. Participants A total of 1,250,000 people. Interventions LAIV for 2- to 11-year-olds and TIV for older people (aged ≥ 65 years) and those aged < 65 years who are at risk of diseases, from 2010/11 to 2015/16. Main outcome measures The main outcome measures include vaccine effectiveness against laboratory-confirmed influenza using real-time reverse-transcription polymerase chain reaction (RT-PCR), influenza-related morbidity and mortality, and adverse events associated with vaccination. Results Two-fifths (40%) of preschool-aged children and three-fifths (60%) of primary school-aged children registered in study practices were vaccinated. Uptake varied among groups [e.g. most affluent vs. most deprived in 2- to 4-year-olds, odds ratio 1.76, 95% confidence interval (CI) 1.70 to 1.82]. LAIV-adjusted vaccine effectiveness among children (aged 2–11 years) for preventing RT-PCR laboratory-confirmed influenza was 21% (95% CI –19% to 47%) in 2014/15 and 58% (95% CI 39% to 71%) in 2015/16. No significant adverse events were associated with LAIV. Among at-risk 18- to 64-year-olds, significant trivalent influenza vaccine effectiveness was found for four of the six seasons, with the highest vaccine effectiveness in 2010/11 (53%, 95% CI 21% to 72%). The seasons with non-significant vaccine effectiveness had low levels of circulating influenza virus (2011/12, 5%; 2013/14, 9%). Among those people aged ≥ 65 years, TIV effectiveness was positive in all six seasons, but in only one of the six seasons (2013/14) was significance achieved (57%, 95% CI 20% to 76%). Conclusions The study found that LAIV was safe and effective in decreasing RT-PCR-confirmed influenza in children. TIV was safe and significantly effective in most seasons for 18- to 64-year-olds, with positive vaccine effectiveness in most seasons for those people aged ≥ 65 years (although this was significant in only one season). Future work The UK Joint Committee on Vaccination and Immunisation has recommended the use of adjuvanted injectable vaccine for those people aged ≥ 65 years from season 2018/19 onwards. A future study will be required to evaluate this vaccine. Trial registration Current Controlled Trials ISRCTN88072400. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 67. See the NIHR Journals Library website for further project information.

scholarly journals Restricted fluid bolus versus current practice in children with septic shock: the FiSh feasibility study and pilot RCT

2018 ◽  
Vol 22 (51) ◽  
pp. 1-106 ◽  
Author(s):  
David Inwald ◽  
Ruth R Canter ◽  
Kerry Woolfall ◽  
Caitlin B O’Hara ◽  
Paul R Mouncey ◽  
...  
Keyword(s):  
Septic Shock ◽  
Health Technology Assessment ◽  
Outcome Measures ◽  
Technology Assessment ◽  
Current Practice ◽  
Health Technology ◽  
Fluid Bolus ◽  
Site Staff ◽  
Pilot Rct ◽  
The Uk

Background There has been no randomised controlled trial (RCT) of fluid bolus therapy in paediatric sepsis in the developed world despite evidence that excess fluid may be associated with harm. Objectives To determine the feasibility of the Fluids in Shock (FiSh) trial – a RCT comparing restricted fluid bolus (10 ml/kg) with current practice (20 ml/kg) in children with septic shock in the UK. Design (1) Qualitative feasibility study exploring parents’ views about the pilot RCT. (2) Pilot RCT over a 9-month period, including integrated parental and staff perspectives study. Setting (1) Recruitment took place across four NHS hospitals in England and on social media. (2) Recruitment took place across 13 NHS hospitals in England. Participants (1) Parents of children admitted to a UK hospital with presumed septic shock in the previous 3 years. (2) Children presenting to an emergency department with clinical suspicion of infection and shock after 20 ml/kg of fluid. Exclusion criteria were receipt of > 20 ml/kg of fluid, conditions requiring fluid restriction and the patient not for full active treatment (i.e. palliative care plan in place). Site staff and parents of children in the pilot were recruited to the perspectives study. Interventions (1) None. (2) Children were randomly allocated (1 : 1) to 10- or 20-ml/kg fluid boluses every 15 minutes for 4 hours if in shock. Main outcome measures (1) Acceptability of FiSh trial, proposed consent model and potential outcome measures. (2) Outcomes were based on progression criteria, including recruitment and retention rates, protocol adherence and separation between the groups, and collection and distribution of potential outcome measures. Results (1) Twenty-one parents were interviewed. All would have consented for the pilot study. (2) Seventy-five children were randomised, 40 to the 10-ml/kg fluid bolus group and 35 to the 20-ml/kg fluid bolus group. Two children were withdrawn. Although the anticipated recruitment rate was achieved, there was variability across the sites. Fifty-nine per cent of children in the 10-ml/kg fluid bolus group and 74% in the 20-ml/kg fluid bolus group required only a single trial bolus before shock resolved. The volume of fluid (in ml/kg) was 35% lower in the first hour and 44% lower over the 4-hour period in the 10-ml/kg fluid bolus group. Fluid boluses were delivered per protocol (volume and timing) for 79% of participants in the 10-ml/kg fluid bolus group and for 55% in the 20-ml/kg fluid bolus group, mainly as a result of delivery not being completed within 15 minutes. There were no deaths. Length of hospital stay, paediatric intensive care unit (PICU) transfers, and days alive and PICU free did not differ significantly between the groups. Two adverse events were reported in each group. A questionnaire was completed by 45 parents, 20 families and seven staff were interviewed and 20 staff participated in focus groups. Although a minority of site staff lacked equipoise in favour of more restricted boluses, all supported the trial. Conclusions Even though a successful feasibility and pilot RCT were conducted, participants were not as unwell as expected. A larger trial is not feasible in its current design in the UK. Future work Further observational work is required to determine the epidemiology of severe childhood infection in the UK in the postvaccine era. Trial registration Current Controlled Trials ISRCTN15244462. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 51. See the NIHR Journals Library website for further project information.

Using information graphics in health technology assessment: Toward a structured approach

2009 ◽  
Vol 25 (4) ◽  
pp. 555-563 ◽  
Author(s):  
Martin Pitt ◽  
Will Stahl-Timmins ◽  
Rob Anderson ◽  
Ken Stein
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Current Practice ◽  
Health Technology ◽  
Information Graphics ◽  
The United Kingdom ◽  
Classification Framework ◽  
Key Stakeholders ◽  
The Uk ◽  
Structured Approach

Objectives: This study investigates the use of information graphics to display the outputs of health technology assessment (HTA) in the United Kingdom and proposes a more structured approach founded in an analysis of the decision-making requirements of the key stakeholders.Methods: A scoping review of HTA reports was conducted to investigate current practice in the use of information graphics in HTA literature. A classification framework using dimensions of report section, graphical type, and originating research center was devised and used for a full content analysis of the graphical figures in the fifty most recent reports produced for the UK National Health Service's HTA process.Results: Our survey shows that graphical tools are used extensively in HTA reports although less frequently than tables. Use of information graphics varies widely between different report sections and tends to follow conventional lines with little evidence of variance from established practice. The largest variance was found between the quantities of graphics used by different research centers responsible for authoring the reports.Conclusions: HTA makes extensive use of graphics; however, there is little evidence of a systematic or standardized approach, or of much innovation. Significant potential exists to explore the application of information graphics in this field, but there are many research challenges. A contextually based, structured approach to the design of effective information graphics in HTA is proposed as a basis both to investigate the application of existing graphical tools in HTA, and to explore the considerable scope for innovation.

OP08 National Institute for Health Research Health Technology Assessment Programme Research Funding And United Kingdom Burden Of Disease

2017 ◽  
Vol 33 (S1) ◽  
pp. 5-6
Author(s):  
Fay Chinnery ◽  
Gemma Bashevoy ◽  
Amanda Blatch-Jones ◽  
Lisa Douet ◽  
Sarah Puddicombe ◽  
...  
Keyword(s):  
United Kingdom ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Burden Of Disease ◽  
Health Research ◽  
Data Exchange ◽  
Market Failure ◽  
Health Technology ◽  
Life Years ◽  
The Uk

INTRODUCTION:This study compared the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) Programme portfolio of research with the united Kingdom (UK) burden of disease, as measured by Disability-Adjusted Life Years (DALYs).METHODS:Design: Cross-sectional study.Setting: The HTA Programme cohort included all funded applications (n = 363) received by the HTA Programme during the period 1 April 2011 to 31 March 2016. The sample contained primary research and evidence syntheses, all purely methodological studies were excluded since these are not comparable to the other study types.Main Outcome Measure: Proportion of spend for each of the twenty-one Health Research Classification System (HRCS) health categories were compared with burden of disease in the UK calculated using 2015 DALY data from the Institute for Health Metrics and Evaluation (IHME) Global Health Data Exchange (GHDx).RESULTS:The funded HTA Programme projects totalled about GBP397million research spend, which broadly reflected the UK DALY burden. Overall, there was less than 5 percent difference between the actual and predicted programme spend based on the burden of disease in the UK in most instances (seventeen out of the twenty-one HRCS Health Categories).The largest categories of apportioned spend were Cancer (accounting for 12.1 percent of portfolio), and Mental Health (11.8 percent of portfolio) which particularly reflected the 9.8 percent burden of disease to the UK. Most notable deviations from DALY, where spend was lower than disease burden, were in the Cancer, Cardiovascular and Musculoskeletal categories; which may reflect the importance of other, notably charity, funding.CONCLUSIONS:The HTA Programme spend broadly aligns with burden of disease as measured using DALYs. Discrepancies were expected owing to the programme remit and its approach to commissioning research to address market failure particularly in areas that are not already well supported by research charities or industry. Regular review of DALY data during research prioritisation and commissioning allows the HTA Programme to identify and address shortfalls in disease areas and to balance its portfolio.

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