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

Abstract

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.