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Evidence for compromised data integrity in studies of liberal peri-operative inspired oxygen
P S Myles1, J B Carlisle2, B Scarr3
1Department of Anaesthesiology and Peri-operative Medicine, Alfred Hospital and Monash University, Melbourne, Vic., Australia.
Abstract:
In 2016 the World Health Organization recommended intra-operative ventilation with 80% inspired oxygen to reduce surgical site infection rates, based upon a meta-analysis of 15 randomised controlled trials, of which two were by Mario Schietroma's research group. Five trials by this group have been retracted for duplication, plagiarism, statistical error and lack of ethical approval. We analysed 40 papers by this group: 24 randomised controlled trials (5064 participants) and 16 observational studies (1847 patients). There was evidence that data integrity was compromised in 38 out of the 40 analysed papers. The distribution of baseline characteristics in randomised controlled trials was unlikely, p = 1.5 × 10-8 : continuous variables within trials were heterogeneous, p = 1.9 × 10-9 , and categorical variables were homogeneous, p = 8.5 × 10-20 . Effects of interventions varied less than expected between studies: for categorical variables, for instance postoperative wound infection, p < 1 × 10-7 , and for continuous variables, for instance HLA-DR concentration, p = 0.00001. Of 184 calculable p values, for baseline variables or results, 179 (98%) were incorrect, ranging from three orders of magnitude too small to 10 orders of magnitude too large. Twenty-one graphs occurred 81 times in 23 out of 40 papers. Liberal peri-operative oxygen did not reduce surgical site infection in a meta-analysis of 20 trials that excluded seven trials by Mario Schietroma and colleagues (odds ratio (95%CI) 0.89 (0.73-1.08); p = 0.23). An update by the World Health Organization has now excluded trials of liberal oxygen by Schietroma's group, four of which have not been retracted. We conclude that Mario Schietroma's work should not inform practice until investigated.
Insights
Concerns regarding data integrity in Mario Schietroma
Area of Science:
- Medical Research Integrity
- Surgical Site Infection Prevention
- Meta-Analysis and Biostatistics
Background:
- The World Health Organization (WHO) recommended 80% inspired oxygen during surgery in 2016 to reduce surgical site infections (SSIs). This recommendation was based on a meta-analysis of 15 randomized controlled trials (RCTs).
- Concerns have arisen regarding the research integrity of Mario Schietroma's research group, whose trials contributed to the original meta-analysis.
- Several of Schietroma's group's trials have faced retractions due to issues including duplication, plagiarism, statistical errors, and lack of ethical approval.
Purpose of the Study:
- To critically evaluate the data integrity and statistical validity of 40 publications (24 RCTs, 16 observational studies) from Mario Schietroma's research group.
- To reassess the evidence base for liberal peri-operative oxygen administration in preventing surgical site infections, particularly concerning the exclusion of potentially flawed studies.
- To determine if Schietroma's group's work should continue to inform clinical practice.
Main Methods:
- Analysis of 40 papers (24 RCTs, 16 observational studies) by Mario Schietroma's research group, focusing on data integrity and statistical properties.
- Statistical assessment of baseline characteristics distribution in RCTs, heterogeneity of continuous and categorical variables, and variability of intervention effects.
- Re-evaluation of meta-analyses on liberal peri-operative oxygen and SSI rates, specifically excluding trials from Schietroma's group.
Main Results:
- Evidence of compromised data integrity was found in 38 out of 40 analyzed papers.
- Statistical analysis revealed highly unlikely distributions of baseline characteristics (p = 1.5 × 10⁻⁸), significant heterogeneity in continuous variables (p = 1.9 × 10⁻⁹), and homogeneity in categorical variables (p = 8.5 × 10⁻²⁰).
- A meta-analysis excluding seven trials by Schietroma's group found no significant reduction in SSI rates with liberal peri-operative oxygen (OR 0.89 (0.73-1.08); p = 0.23).
Conclusions:
- The data integrity of a significant portion of Mario Schietroma's research group's publications is questionable, with widespread statistical anomalies.
- The original recommendation for 80% inspired oxygen to reduce SSIs, partly based on this group's work, is unsupported by a re-analysis excluding their trials.
- Schietroma's research should not influence clinical practice until a thorough investigation addresses the identified data integrity and ethical concerns.
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