False individual patient data and zombie randomised controlled trials submitted toAnaesthesia

Concerned that studies contain false data, I analysed the baseline summary data of randomised controlled trials when they were submitted toAnaesthesiafrom February 2017 to March 2020. I categorised trials with false data as 'zombie' if I thought that the trial was fatally flawed. I analysed 526 submitted trials: 73 (14%) had false data and 43 (8%) I categorised zombie. Individual patient data increased detection of false data and categorisation of trials as zombie compared with trials without individual patient data: 67/153 (44%) false vs. 6/373 (2%) false; and 40/153 (26%) zombie vs. 3/373 (1%) zombie, respectively. The analysis of individual patient data was independently associated with false data (odds ratio (95% credible interval) 47 (17-144); p = 1.3 x 10(-12)) and zombie trials (odds ratio (95% credible interval) 79 (19-384); p = 5.6 x 10(-9)). Authors from five countries submitted the majority of trials: China 96 (18%); South Korea 87 (17%); India 44 (8%); Japan 35 (7%); and Egypt 32 (6%). I identified trials with false data and in turn categorised trials zombie for: 27/56 (48%) and 20/56 (36%) Chinese trials; 7/22 (32%) and 1/22 (5%) South Korean trials; 8/13 (62%) and 6/13 (46%) Indian trials; 2/11 (18%) and 2/11 (18%) Japanese trials; and 9/10 (90%) and 7/10 (70%) Egyptian trials, respectively. The review of individual patient data of submitted randomised controlled trials revealed false data in 44%. I think journals should assume that all submitted papers are potentially flawed and editors should review individual patient data before publishing randomised controlled trials.

Automated summary

The author analyzed the baseline summary data of randomized controlled trials submitted to Anaesthesia from 2017 to 2020, identifying 14% of trials containing false data and categorizing 8% as 'zombie'. The analysis showed that individual patient data increased detection of false data and categorization of trials as 'zombie'. China, South Korea, India, Japan, and Egypt were the top five countries submitting trials, with China having the highest proportion.