scholarly journals E-cigarettes compared with nicotine replacement therapy within the UK Stop Smoking Services: the TEC RCT

2019 ◽  
Vol 23 (43) ◽  
pp. 1-82 ◽  
Author(s):  
Peter Hajek ◽  
Anna Phillips-Waller ◽  
Dunja Przulj ◽  
Francesca Pesola ◽  
Katie Myers Smith ◽  
...  
Keyword(s):  
Technology Assessment ◽  
Health Technology ◽  
Time Points ◽  
Quit Attempt ◽  
Stop Smoking ◽  
Quit Rate ◽  
Stop Smoking Services ◽  
Cost Efficacy ◽  
Seeking Help ◽  
The Uk

BackgroundOver the past few years, a large number of smokers in the UK have stopped smoking with the help of e-cigarettes. So far, UK Stop Smoking Services (SSSs) have been reluctant to include e-cigarettes among their treatment options because data on their efficacy compared with the licensed medications are lacking.ObjectiveThe objective was to compare the efficacy of refillable e-cigarettes and nicotine replacement therapy (NRT) products, when accompanied by weekly behavioural support.DesignA randomised controlled trial comparing e-cigarettes and NRT.SettingThree sites that provide local SSSs.ParticipantsThe participants were 886 smokers seeking help to quit smoking, aged ≥ 18 years, not pregnant or breastfeeding, with no strong preference to use or not to use NRT or e-cigarettes in their quit attempt, and currently not using NRT or e-cigarettes. A total of 886 participants were randomised but two died during the study (one in each study arm) and were not included in the analysis.InterventionsThe NRT arm (n = 446) received NRT of their choice (single or combination), provided for up to 12 weeks. The e-cigarette arm (n = 438) received an e-cigarette starter pack and were encouraged to buy addtional e-liquids and e-cigarette products of their choice. Both arms received the same standard behavioural support. Participants attended weekly sessions at their SSS and provided outcome data at 4 weeks. They were then followed up by telephone at 6 and 12 months. Participants reporting abstinence or at least 50% reduction in cigarette consumption at 12 months were invited to attend for carbon monoxide (CO) validation. Participants/researchers could not be blinded to the intervention.Main outcome measuresThe primary outcome was CO-validated sustained abstinence rates at 52 weeks. Participants lost to follow-up or not providing biochemical validation were included as non-abstainers. Secondary outcomes included abstinence at other time points, reduction in smoke intake, treatment adherence and ratings, elicited adverse reactions, and changes in self-reported respiratory health. A cost-efficacy analysis of the intervention was also conducted.ResultsThe 1-year quit rate was 9.9% in the NRT arm and 18.0% in the e-cigarette arm (risk ratio 1.83, 95% confidence interval 1.30 to 2.58;p < 0.001). The e-cigarette arm had significantly higher validated quit rates at all time points. Participants in the e-cigarette arm showed significantly better adherence and experienced fewer urges to smoke throughout the initial 4 weeks of their quit attempt than those in the NRT arm, and gave their allocated product more favourable ratings. They were also more likely to be still using their allocated product at 1 year (39.5% vs. 4.3%, χ2 = 161.4;p < 0.001). Participants assigned to e-cigarettes reported significantly less coughing and phlegm at 1 year than those assigned to NRT (controlling for smoking status). A detailed economic analysis confirmed that, because e-cigarettes incur lower NHS costs than NRT and generate a higher quit rate, e-cigarette use is more cost-effective.LimitationsThe results may not be generalisable to other types of smokers or settings, or to cartridge-based e-cigarettes.ConclusionsWithin the context of multisession treatment for smokers seeking help, e-cigarettes were significantly more effective than NRT. If SSSs provide e-cigarette starter packs, it is likely to boost their success rates and improve their cost-efficacy.Future workThe efficacy of e-cigarettes provided with different levels of support will show whether smokers should be encouraged to switch to vaping within support services or whether e-cigarettes can be recommended with less intensive or no support.Trial registrationCurrent Controlled Trials ISRCTN60477608.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 23, No. 43. See the NIHR Journals Library website for further project information. The trial was supported by the Cancer Research UK Prevention Trials Unit (grant A16893).

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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