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In February 2019, data integrity from 38 published randomised controlled trials in surgical patients conducted by an Italian surgical research group was called into question (Buranyi and Devlin 2019). Using the Carlisle method, Myles, Carlisle and Scarr identified evidence of compromised data in 38 out of 40 published articles from Mario Schietroma’s research group spanning from years 1993 to 2016 (Myles et al. 2019). In their analysis, they meta-analysed all published patient characteristic data, identifying poorly distributed participant characteristics, incorrect ‘p’ values and overly consistent results. There was enough evidence from this analysis to recommend an inquiry into the group’s work, and their published outputs are likely to have been misleading researchers within the field of perioperative medicine for some years (Myles et al. 2019). Such alleged misconduct is not only damaging to the scientific community and to perioperative research, but may also have substantial global consequences for patient safety through the impact of flawed research on doctors’ prescribing habits. Two of Schietroma’s papers had been referenced by the World Health Organisation’s (WHO) ‘Global guidelines for the prevention of surgical site infection’ and included in their meta-analysis on perioperative oxygenation published initially in 2016. In this, they made a strong recommendation (subsequently downgraded to ‘conditional’ in 2018) to provide 80% oxygen to all intubated patients undergoing surgery requiring general anaesthesia and intubation (Global guidelines for the prevention of surgical site infection 2018). To put this value into perspective, this is a recommendation to give surgical patients almost four times more inspired oxygen than is physiologically normal under healthy conditions. The field of perioperative oxygen research is perplexing even for the well initiated. There seems to be a real contradiction between prescribing recommendations and trial evidence. Early studies reporting the beneficial effects of high-dose perioperative oxygen therapy in reducing surgical site infections and postoperative complications provided the majority of evidence for the 2016 WHO guidelines (Greif et al. 2000; Belda et al. 2005; Myles et al. 2007). These results, however, were not supported by data from a much larger trial, which showed no impact on surgical site infections from higher inspired oxygen concentrations (Meyhoff et al. 2009). Additionally, a Cochrane systematic review and metaanalysis published in 2015 concluded that there was insufficient evidence to support routinely giving anaesthetised patients more than 60% oxygen intraoperatively (Wetterslev et al. 2015). The most up-to-date systematic reviews and meta-analyses support the modified WHO recommendation, suggesting that there is “little evidence on safety-related issues” and “no definite signal of harm” with administering an 80% oxygen in adult patients undergoing general anaesthesia (de Jonge et al. 2019; Mattishent et al. 2019). These reviews support the fact that there remains little evidence for definite benefit of high perioperative fractions of oxygen and suggest that evidence for giving 80% oxygen in order to reduce the risk of surgical site infections has substantively changed, calling for the international recommendations to be urgently reconsidered (de Jonge et al. 2019). Importantly, clinical outcome studies in patients in other contexts have provided evidence of harm from highdose oxygen. Notably, the Improving Oxygen Therapy in

Data integrity issues: catalyst for a more robust approach to research on perioperative oxygen therapy?