ObjectivesCOVID-19 presents a risk of infection and transmission for operating theatre teams. Guidelines to protect patients and staff emerged and changed rapidly based on expert opinion and limited evidence. This paper presents the experiences and innovations developed by international surgical teams during the early stages of the pandemic to attempt to mitigate risk.DesignIn-depth, semistructured interviews were audio recorded, transcribed and analysed thematically using methods of constant comparison.Participants43 participants, including surgeons from a range of specialties (primarily general surgery, otolaryngology, neurosurgery, cardiothoracic and ophthalmology), anaesthetists and those in nursing roles.SettingThe UK, Italy, Spain, the USA, China and New Zealand between March and May 2020.ResultsSurgical teams sought to mitigate COVID-19 risks by modifying their current practice with an abundance of strategies and innovations. Communication and teamwork played an integral role in how teams adapted, although participants reflected on the challenges of having to improvise in real time. Uncertainties remained about optimal surgical practice and there were significant tensions where teams were forced to balance what was best for patients while contemplating their own safety.ConclusionsThe perceptions of risks during a pandemic such as COVID-19 can be complex and context dependent. Management of these risks in surgery must be driven by evidence‐based practice resulting from a pragmatic and novel approach to collation of global evidence. The context of surgery has changed dramatically, and surgical teams have developed a plethora of innovations. There is an urgent need for high-quality evidence to inform surgical practice that optimises the safety of both patients and healthcare professionals as the COVID-19 pandemic unfolds.
IntroductionRandomised 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).ObjectiveThis 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 analysisWe 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 disseminationEthics 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 numberISRCTN59036820,ISRCTN10386621.
IntroductionThe development of innovative invasive procedures and devices are essential to improving outcomes in healthcare. However, how these are introduced into practice has not been studied in detail. The Lotus study will follow a wide range of ‘case studies’ of new procedures and/or devices being introduced into NHS trusts to explore what information is communicated to patients, how procedures are modified over time and how outcomes are selected and reported.Methods and analysisThis qualitative study will use ethnographic approaches to investigate how new invasive procedures and/or devices are introduced. Consultations in which the innovation is discussed will be audio-recorded to understand information provision practice. To understand if and how procedures evolve, they will be video recorded and non-participant observations will be conducted. Post-operative interviews will be conducted with the innovating team and patients who are eligible for the intervention. Audio-recordings will be audio-recorded, transcribed verbatim and analysed thematically using constant comparison techniques. Video-recordings will be reviewed to deconstruct procedures into key components and document how the procedure evolves. Comparisons will be made between the different data sources.Ethics and disseminationThe study protocol has Health Research Authority (HRA) and Health and Care Research Wales approval (Ref 18/SW/0277). Results will be disseminated at appropriate conferences and will be published in peer-reviewed journals. The findings of this study will provide a better understanding of how innovative invasive procedures and/or devices are introduced into practice.
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