Protocol for developing quality assurance measures to use in surgical trials:an example from the ROMIO study

INTRODUCTION: Randomised controlled trials (RCTs) in surgery are frequently criticised because surgeon expertise and standards of surgery are not considered or accounted for during study design. This is particularly true in pragmatic trials (which typically involve multiple centres and surgeons and are based in 'real world' settings), compared with explanatory trials (which are smaller and more tightly controlled).OBJECTIVE: This protocol describes a process to develop and test quality assurance (QA) measures for use within a predominantly pragmatic surgical RCT comparing minimally invasive and open techniques for oesophageal cancer (the NIHR ROMIO study). It builds on methods initiated in the ROMIO pilot RCT.METHODS AND ANALYSIS: We have identified three distinct types of QA measure: (i) entry criteria for surgeons, through assessment of operative videos, (ii) standardisation of operative techniques (by establishing minimum key procedural phases) and (iii) monitoring of surgeons during the trial, using intraoperative photography to document key procedural phases and standardising the pathological assessment of specimens. The QA measures will be adapted from the pilot study and tested iteratively, and the video and photo assessment tools will be tested for reliability and validity.ETHICS AND DISSEMINATION: Ethics approval was obtained (NRES Committee South West-Frenchay, 25 April 2016, ref: 16/SW/0098). Results of the QA development study will be submitted for publication in a peer-reviewed journal.Trial registration number: ISRCTN59036820, ISRCTN10386621.</p

The school Lifesavers study - a randomised controlled trial comparing the impact of Lifesaver only, face-to-face training only, and Lifesaver with face-to-face training on CPR knowledge, skills and attitudes in UK school children

Background: Lifesaver (www.life-saver.org.uk) is an immersive, interactive game that can be used for basic life support training. Users ‘resuscitate’ a victim of cardiac arrest in a filmed scenario and move their device up and down to simulate cardiac compressions. Methods: Randomised controlled trial of 3 UK schools (81 students) comparing Lifesaver, face-to-face (F2F) training, and a combination of both. Primary outcomes: mean chest compression rate and depth. Secondary outcomes: flow fraction, CPR performance, and attitude survey. Outcomes measured immediately, 3 and 6 months. Results: Primary outcomes: Mean chest compression depth was suboptimal in all groups due to body size. F2F performed better than Lifesaver initially (−11.676; 95% CI −18.34 to −5.01; p = 0.0001) but no difference at 3 months (p = 0.493) and 6 months (p = 0.809). No difference in mean compression rates for Lifesaver vs F2F (−11.89; 95% CI −30.39 to −6.61; p = 0.280) and combined vs Lifesaver (0.25; 95% CI −17.4 to −17.9; p = 0.999). Secondary outcomes: all groups had flow fraction >60% after training. Combined group performed better for skills assessment than Lifesaver (4.02; 95% CI 2.81–5.22; p = 0.001) and F2F (1.76; 95 CI 0.51–3; p = 0.003); and the same at 6 months (1.92; 95% CI 0.19–3.64; p = 0.026 and 1.96; 95% CI 0.17–3.75; p = 0.029). Conclusions: Use of Lifesaver by school children, compared to F2F training alone, can lead to comparable learning outcomes for several key elements of successful CPR. Its use can be considered where resources or time do not permit formal F2F training sessions. The true benefits of Lifesaver can be realised if paired with F2F training

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

The Winchcombe meteorite, a unique and pristine witness from the outer solar system.

Direct links between carbonaceous chondrites and their parent bodies in the solar system are rare. The Winchcombe meteorite is the most accurately recorded carbonaceous chondrite fall. Its pre-atmospheric orbit and cosmic-ray exposure age confirm that it arrived on Earth shortly after ejection from a primitive asteroid. Recovered only hours after falling, the composition of the Winchcombe meteorite is largely unmodified by the terrestrial environment. It contains abundant hydrated silicates formed during fluid-rock reactions, and carbon- and nitrogen-bearing organic matter including soluble protein amino acids. The near-pristine hydrogen isotopic composition of the Winchcombe meteorite is comparable to the terrestrial hydrosphere, providing further evidence that volatile-rich carbonaceous asteroids played an important role in the origin of Earth's water

Effect of Noninvasive Respiratory Strategies on Intubation or Mortality Among Patients With Acute Hypoxemic Respiratory Failure and COVID-19: The RECOVERY-RS Randomized Clinical Trial.

Importance Continuous positive airway pressure (CPAP) and high-flow nasal oxygen (HFNO) have been recommended for acute hypoxemic respiratory failure in patients with COVID-19. Uncertainty exists regarding the effectiveness and safety of these noninvasive respiratory strategies. Objective To determine whether either CPAP or HFNO, compared with conventional oxygen therapy, improves clinical outcomes in hospitalized patients with COVID-19-related acute hypoxemic respiratory failure. Design, Setting, and Participants A parallel group, adaptive, randomized clinical trial of 1273 hospitalized adults with COVID-19-related acute hypoxemic respiratory failure. The trial was conducted between April 6, 2020, and May 3, 2021, across 48 acute care hospitals in the UK and Jersey. Final follow-up occurred on June 20, 2021. Interventions Adult patients were randomized to receive CPAP (n = 380), HFNO (n = 418), or conventional oxygen therapy (n = 475). Main Outcomes and Measures The primary outcome was a composite of tracheal intubation or mortality within 30 days. Results The trial was stopped prematurely due to declining COVID-19 case numbers in the UK and the end of the funded recruitment period. Of the 1273 randomized patients (mean age, 57.4 [95% CI, 56.7 to 58.1] years; 66% male; 65% White race), primary outcome data were available for 1260. Crossover between interventions occurred in 17.1% of participants (15.3% in the CPAP group, 11.5% in the HFNO group, and 23.6% in the conventional oxygen therapy group). The requirement for tracheal intubation or mortality within 30 days was significantly lower with CPAP (36.3%; 137 of 377 participants) vs conventional oxygen therapy (44.4%; 158 of 356 participants) (absolute difference, -8% [95% CI, -15% to -1%], P = .03), but was not significantly different with HFNO (44.3%; 184 of 415 participants) vs conventional oxygen therapy (45.1%; 166 of 368 participants) (absolute difference, -1% [95% CI, -8% to 6%], P = .83). Adverse events occurred in 34.2% (130/380) of participants in the CPAP group, 20.6% (86/418) in the HFNO group, and 13.9% (66/475) in the conventional oxygen therapy group. Conclusions and Relevance Among patients with acute hypoxemic respiratory failure due to COVID-19, an initial strategy of CPAP significantly reduced the risk of tracheal intubation or mortality compared with conventional oxygen therapy, but there was no significant difference between an initial strategy of HFNO compared with conventional oxygen therapy. The study may have been underpowered for the comparison of HFNO vs conventional oxygen therapy, and early study termination and crossover among the groups should be considered when interpreting the findings. Trial Registration isrctn.org Identifier: ISRCTN16912075