Economic evaluation of the OSAC randomised controlled trial:oral corticosteroids for non-asthmatic adults with acute lower respiratory tract infection in primary care

ObjectiveTo estimate the costs and outcomes associated with treating non-asthmatic adults (nor suffering from other lung-disease) presenting to primary care with acute lower respiratory tract infection (ALRTI) with oral corticosteroids compared with placebo.DesignCost-consequence analysis alongside a randomised controlled trial. Perspectives included the healthcare provider, patients and productivity losses associated with time off work.SettingFifty-four National Health Service (NHS) general practices in England.Participants398 adults attending NHS primary practices with ALRTI but no asthma or other chronic lung disease, followed up for 28 days.Interventions2× 20 mg oral prednisolone per day for 5 days versus matching placebo tablets.Outcome measuresQuality-adjusted life years using the 5-level EuroQol-5D version measured weekly; duration and severity of symptom. Direct and indirect resources related to the disease and its treatment were also collected. Outcomes were measured for the 28-day follow-up.Results198 (50%) patients received the intervention (prednisolone) and 200 (50%) received placebo. NHS costs were dominated by primary care contacts, higher with placebo than with prednisolone (£13.11 vs £10.38) but without evidence of a difference (95% CI £3.05 to £8.52). The trial medication cost of £1.96 per patient would have been recouped in prescription charges of £4.30 per patient overall (55% participants would have paid £7.85), giving an overall mean ‘profit’ to the NHS of £7.00 (95% CI £0.50 to £17.08) per patient. There was a quality adjusted life years gain of 0.03 (95% CI 0.01 to 0.05) equating to half a day of perfect health favouring the prednisolone patients; there was no difference in duration of cough or severity of symptoms.ConclusionsThe use of prednisolone for non-asthmatic adults with ALRTI, provided small gains in quality of life and cost savings driven by prescription charges. Considering the results of the economic evaluation and possible side effects of corticosteroids, the short-term benefits may not outweigh the long-term harms.Trial registration numbersEudraCT 2012-000851-15 and ISRCTN57309858; Pre-results

Economic evaluation of the OSAC randomised controlled trial: Oral corticosteroids for non-asthmatic adults with acute lower respiratory tract infection in primary care

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ. Objective To estimate the costs and outcomes associated with treating non-asthmatic adults (nor suffering from other lung-disease) presenting to primary care with acute lower respiratory tract infection (ALRTI) with oral corticosteroids compared with placebo. Design Cost-consequence analysis alongside a randomised controlled trial. Perspectives included the healthcare provider, patients and productivity losses associated with time off work. Setting Fifty-four National Health Service (NHS) general practices in England. Participants 398 adults attending NHS primary practices with ALRTI but no asthma or other chronic lung disease, followed up for 28 days. Interventions 2× 20 mg oral prednisolone per day for 5 days versus matching placebo tablets. Outcome measures Quality-adjusted life years using the 5-level EuroQol-5D version measured weekly; duration and severity of symptom. Direct and indirect resources related to the disease and its treatment were also collected. Outcomes were measured for the 28-day follow-up. Results 198 (50%) patients received the intervention (prednisolone) and 200 (50%) received placebo. NHS costs were dominated by primary care contacts, higher with placebo than with prednisolone (£13.11 vs £10.38) but without evidence of a difference (95% CI £3.05 to £8.52). The trial medication cost of £1.96 per patient would have been recouped in prescription charges of £4.30 per patient overall (55% participants would have paid £7.85), giving an overall mean 'profit' to the NHS of £7.00 (95% CI £0.50 to £17.08) per patient. There was a quality adjusted life years gain of 0.03 (95% CI 0.01 to 0.05) equating to half a day of perfect health favouring the prednisolone patients; there was no difference in duration of cough or severity of symptoms. Conclusions The use of prednisolone for non-asthmatic adults with ALRTI, provided small gains in quality of life and cost savings driven by prescription charges. Considering the results of the economic evaluation and possible side effects of corticosteroids, the short-term benefits may not outweigh the long-term harms. Trial registration numbers EudraCT 2012-000851-15 and ISRCTN57309858; Pre-results

Protocol for a cluster randomised controlled trial of an intervention to improve the mental health support and training available to secondary school teachers - the WISE (Wellbeing in Secondary Education) study.

BACKGROUND: Teachers are reported to be at increased risk of common mental health disorders compared to other occupations. Failure to support teachers adequately may lead to serious long-term mental disorders, poor performance at work (presenteeism), sickness absence and health-related exit from the profession. It also jeopardises student mental health, as distressed staff struggle to develop supportive relationships with students, and such relationships are protective against student depression. A number of school-based trials have attempted to improve student mental health, but these have mostly focused on classroom based approaches and have failed to establish effectiveness. Only a few studies have introduced training for teachers in supporting students, and none to date have included a focus on improving teacher mental health. This paper sets out the protocol (version 4.4 20/07/16) for a study aiming to address this gap. METHODS: Cluster randomised controlled trial with secondary schools as the unit of randomisation. Intervention schools will receive: i) Mental Health First Aid (MHFA) training for a group of staff nominated by their colleagues, after which they will set up a confidential peer support service for colleagues ii) training in MHFA for schools and colleges for a further group of teachers, which will equip them to more effectively support student mental health iii) a short mental health awareness raising session and promotion of the peer support service for all teachers. Comparison schools will continue with usual practice. The primary outcome is teacher wellbeing measured using the Warwick Edinburgh Mental Wellbeing Scale (WEMWBS). Secondary outcomes are teacher depression, absence and presenteeism, and student wellbeing, mental health difficulties, attendance and attainment. Measures will be taken at baseline, one year follow up (teachers only) and two year follow up. Economic and process evaluations will be embedded within the study. DISCUSSION: This study will establish the effectiveness and cost-effectiveness of an intervention that supports secondary school teachers' wellbeing and mental health, and improves their skills in supporting students. It will also provide information regarding intervention implementation and sustainability. TRIAL REGISTRATION: International Standard Randomised Controlled Trial Number: ISRCTN95909211 registered 24/03/16

Active for Life Year 5: a cluster randomised controlled trial of a primary school-based intervention to increase levels of physical activity, decrease sedentary behaviour and improve diet

Background: Previous studies of the effect of school-based interventions to improve healthy behaviours have had important limitations. Objective: To investigate the effectiveness of a school-based intervention to increase physical activity, reduce sedentary behaviour and increase fruit and vegetable consumption. Design: Cluster randomised controlled trial. Setting: Sixty English primary schools. Participants: Children in year 4 (aged 8–9 years) at recruitment, year 5 (aged 9–10 years) during the intervention and immediate follow-up and year 6 (aged 10–11 years) during 1 year of follow-up. Intervention: Active for Life Year 5 (AFLY5) included teacher training, lesson plans, materials for 16 lessons, parent-interactive homework and written materials for school newsletters and parents. Main outcome measures: Primary outcome measures included accelerometer-assessed levels of physical activity and sedentary behaviour, and child-reported consumption of fruit and vegetables. Secondary outcome measures included child-reported screen viewing; consumption of snacks, high-fat food and high-energy drinks; body mass index; and waist circumference. Results: We recruited 60 schools (2221 children). At the immediate follow-up, no difference was found between children in intervention and control schools for any of the three primary outcomes. The intervention was effective on three of the nine secondary outcomes; children in intervention schools reported spending less time screen viewing at weekends [–21 minutes per day, 95% confidence interval (CI) –37 to –4 minutes per day], eating fewer servings of snacks per day (–0.22, 95% CI –0.38 to –0.05 servings of snacks per day) and drinking fewer servings of high-energy drinks per day (–0.26, 95% CI –0.43 to –0.10 servings of high-energy drinks per day) than the children in control schools. The results remained consistent 1 year later. The intervention increased children’s perception of maternal efforts to limit the time they spent screen viewing and children’s knowledge about healthy physical activity and fruit and vegetable consumption, with these two mediators explaining approximately one-quarter of the effect of the intervention on screen viewing. The intervention did not affect other mediators. The cost of implementing the intervention from a provider perspective was approximately £18 per child. Process evaluation showed that AFLY5 was implemented with a high degree of fidelity. Teachers supported the aims of AFLY5, but their views of the programme itself were mixed. Limitations: Responses to parental questionnaires for the economic evaluation were low and we struggled to engage all teachers for the process evaluation. Although the participating schools included a range of levels of socioeconomic deprivation, class sizes and rural and urban settings, we cannot assume that results generalise to all primary schools. Conclusions: AFLY5 is not effective at increasing levels of physical activity, reducing sedentary behaviour and increasing fruit and vegetable consumption in primary school children, but may be effective in reducing time spent screen viewing at weekends and the consumption of snacks and high-energy drinks. Future work: Our findings suggest that school-based interventions are unlikely to have a major impact on promoting healthy levels of physical activity and healthy diets in primary school children. We would recommend trials of the effect and cost-effectiveness of more intensive family and community interventions. Trial registration: Current Controlled Trials ISRCTN50133740. Funding: This project was funded by the National Institute for Health Research Public Health Research programme and will be published in full in Public Health Research; Vol. 4, No. 7. See the NIHR Journals Library website for further project information

Comparing open and minimally invasive surgical procedures for oesophagectomy in the treatment of cancer: the ROMIO (Randomised Oesophagectomy: Minimally Invasive or Open) feasibility study and pilot trial

Background: Localised oesophageal cancer can be curatively treated with surgery (oesophagectomy) but the procedure is complex with a risk of complications, negative effects on quality of life and a recovery period of 6–9 months. Minimal-access surgery may accelerate recovery. Objectives: The ROMIO (Randomised Oesophagectomy: Minimally Invasive or Open) study aimed to establish the feasibility of, and methodology for, a definitive trial comparing minimally invasive and open surgery for oesophagectomy. Objectives were to quantify the number of eligible patients in a pilot trial; develop surgical manuals as the basis for quality assurance; standardise pathological processing; establish a method to blind patients to their allocation in the first week post surgery; identify measures of postsurgical outcome of importance to patients and clinicians; and establish the main cost differences between the surgical approaches. Design: Pilot parallel three-arm randomised controlled trial nested within feasibility work. Setting: Two UK NHS departments of upper gastrointestinal surgery. Participants: Patients aged ≥ 18 years with histopathological evidence of oesophageal or oesophagogastric junctional adenocarcinoma, squamous cell cancer or high-grade dysplasia, referred for oesophagectomy or oesophagectomy following neoadjuvant chemo(radio)therapy. Interventions: Oesophagectomy, with patients randomised to open surgery, a hybrid open chest and minimally invasive abdomen or totally minimally invasive access. Main outcome measure: The primary outcome measure for the pilot trial was the number of patients recruited per month, with the main trial considered feasible if at least 2.5 patients per month were recruited. Results: During 21 months of recruitment, 263 patients were assessed for eligibility; of these, 135 (51%) were found to be eligible and 104 (77%) agreed to participate, an average of five patients per month. In total, 41 patients were allocated to open surgery, 43 to the hybrid procedure and 20 to totally minimally invasive surgery. Recruitment is continuing, allowing a seamless transition into the definitive trial. Consequently, the database is unlocked at the time of writing and data presented here are for patients recruited by 31 August 2014. Random allocation achieved a good balance between the arms of the study, which, as a high proportion of patients underwent their allocated surgery (69/79, 87%), ensured a fair comparison between the interventions. Dressing patients with large bandages, covering all possible incisions, was successful in keeping patients blind while pain was assessed during the first week post surgery. Postsurgical length of stay and risk of adverse events were within the typical range for this group of patients, with one death occurring within 30 days among 76 patients. There were good completion rates for the assessment of pain at 6 days post surgery (88%) and of the patient-reported outcomes at 6 weeks post randomisation (74%). Conclusions: Rapid recruitment to the pilot trial and the successful refinement of methodology indicated the feasibility of a definitive trial comparing different approaches to oesophagectomy. Although we have shown a full trial of open compared with minimally invasive oesophagectomy to be feasible, this is necessarily based on our findings from the two clinical centres that we could include in this small preliminary study. Trial registration: Current Controlled Trials ISRCTN59036820. Funding: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 20, No. 48. See the NIHR Journals Library website for further project information

Marketing conception of floorball brand

The main objektive of this thesis is to analyze the market position of floorball brand Canadien and to suggest improvements for marketing conception of Charlies and Co. company (exclusive distributor of brand Canadien in the Czech Republic). The theoretical part analyses czech floorball market, divides it into different segments and presents the results of marketing research specialized on evaluation of the main floorball brands in the Czech Republic. The most important information about the market and the brand Canadien are summarized in Swot analysis. The end of the thesis is devoted to suggestion of appropriate future brand strategy and concrete steps for each part of the marketing mix