Evidence for compromised data integrity in studies of liberal peri‐operative inspired oxygen
Open accessAbstract
Summary: 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 Five trials by this group have been retracted for duplication, plagiarism, statistical error and lack of ethical approval.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the World Health Organization has now excluded trials of liberal oxygen by Schietroma's group, four of which have not been retracted.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.
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Cites
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Claims the paper makes
0 of 20 cited sources checked · 0 supported · 0 flagged
- Findingown data
In another paper, the calculated p value for five categories of hiatus hernia across three groups was 0.835, 835 times larger than the reported p = 0.001.
“In another paper, five categories of hiatus hernia (none/large type 1/large type 2/ small type 1/small type 2) in three groups were: 1/0/2/0/40; 3/1/8/1/76; and 5/1/5/2/56, respectively, for which p = 0.835, 835 times larger than the reported p = 0.001”
Quote in the paperSubstantial claim - Findingown data
Evidence indicated that data integrity was compromised in 38 of the 40 analysed papers.
“There was evidence that data integrity was compromised in 38 out of 40 analysed papers (Table 1 and Supporting Information Appendix S1).”
- Also stated in: § Abstract · plain
“There was evidence that data integrity was compromised in 38 out of the 40 analysed papers.”
Quote in the paperSubstantial claim - Also stated in: § Abstract · plain
- Findingown data
Twenty-one graphs were used 81 times in 23 of the 40 papers.
“Twenty-one graphs were used 81 times in 23 out of 40 papers (Table 2 and Supporitng Information Appendix S1).”
- Also stated in: § Abstract · plain
“Twenty-one graphs occurred 81 times in 23 out of 40 papers.”
Quote in the paperSubstantial claim - Also stated in: § Abstract · plain
- Findingown data
Differences for outcomes varied little between papers for both randomised controlled trials and observational studies.
“There was a similar pattern of little variation in differences for outcomes between papers, both randomised controlled trials and observational studies.”
Quote in the paperSubstantial claim - Findingnone given
No trial had been registered in advance on a public website.
“None of the trials had been preregistered on a publicly available website.”
Quote in the paperSubstantial claim
- Findingown data
Relative rates of wound infection were invariant even when the experimental intervention was not liberal inspired oxygen.
“Notably, relative rates of wound infection, pivotal for the WHO guideline, were invariant even when the experimental intervention was not liberal inspired oxygen (Fig. 4).”
- Also stated in: § Discussion · plain
“There was little variation in effect between studies across all interventions, p < 1 9 10 À7 .”
Quote in the paperSubstantial claim - Also stated in: § Discussion · plain
- Findingown data
Relative risks, odds ratios and sums were incorrectly calculated 36 times.
“Relative risks, ORs and sums were incorrectly calculated 36 times (Table 1 and Supporting Information Appendix S1).”
Quote in the paperSubstantial claim - Findingown data
Pooled results excluding Schietroma trials, both retracted and not, did not show an effect of liberal peri-operative inspired oxygen on wound infection (OR 0.89, 95% CI 0.73-1.08; p = 0.23).
“Pooled results without trials by Schietroma et al., both retracted[1,4,5] and not[28,38,43,49], did not show an effect of liberal peri-operative inspired oxygen on wound infection (OR (95%CI) 0.89 (0.73-1.08); p = 0.23 (Fig.6)).”
Quote in the paperSubstantial claim0 of 7 sources checked - Findingown data
Among the 96 reported p values that could also be calculated precisely, one was correct.
“One of the 96 reported p values that we could also calculate precisely were correct (red crosses).”
Quote in the paperSubstantial claim - Findingown data
Of 184 p values reported exactly, 179 (97%) were incorrect.
“including 179/184 (97%) incorrect p values reported exactly ('=' rather than '>'or '<')”
- Also stated in: § Abstract · plain
“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.”
Quote in the paperSubstantial claim - Also stated in: § Abstract · plain
- Findingown data
Baseline characteristics in the randomised controlled trials did not match expected distributions (Anderson-Darling p = 2.85 × 10^-6; Kolmogorov-Smirnov p = 1.56 × 10^-11).
“The distributions of baseline characteristics in randomised controlled trials were inconsistent with the expected distributions, p = 2.85 9 10 À6 (Anderson-Darling test) and p = 1.56 9 10 À11 (Kolmogorov-Smirnov test) (Fig. 1).”
- Also stated in: § Discussion · plain
“The observed cumulative distribution (black circles) is inconsistent with the expected distribution (dashed red line), p = 2.86 9 10 À6 .”
Quote in the paperSubstantial claim - Also stated in: § Discussion · plain
- Findingown data
Liberal inspired oxygen reduced postoperative wound infection when Schietroma trials were included (OR 0.77, 95% CI 0.61-0.96; p = 0.02).
“Liberal inspired oxygen reduced the rate of postoperative wound infection if trials by Schietroma et al. were included (OR (95%CI) 0.77 (0.61-0.96); p = 0.02 (see also Supporting Information Figures S7-S17)).”
Quote in the paperSubstantial claim - Findingown data
Figures were replicated across 40 papers published by the same author group.
“The replication of figures within 40 papers published by the same author group.”
Quote in the paperSubstantial claim - Findingown data
Of those 184 p values, 5 (3%) were correct, as indicated by a ratio to the reported precise p value equal to one.
“Five ratios equalled one, that is, 5/184 (3%) p values were correct.”
Quote in the paperSubstantial claim - Findingown data
Of 825 reported p values, 344 (42%) were incorrect.
“Out of 825 reported p values, 344 (42%) were incorrect, including 179/184 (97%) incorrect p values reported exactly ('=' rather than '>'or '<') (Fig. 5 and Supporting Information Data S1 and Fig. S11).”
Quote in the paperSubstantial claim - Findingown data
Categorical variables were homogeneous between groups within and between studies.
“The distribution of categorical variables was homogeneous between groups within and between studies (Table 1 and Fig. 2).”
- Also stated in: § Discussion · plain
“The probability that the distribution of sexes in randomised controlled trials was less varied than observed was < 1 9 10 À6 .”
Quote in the paperSubstantial claim - Also stated in: § Discussion · plain
- Findingown data
In one paper, the calculated p value for initial postoperative pain scores was 5.07 × 10^-12, ten orders of magnitude smaller than the reported p = 0.042.
“For instance, in one paper the mean (SD) initial postoperative pain scores were 5.7 (1.26) and 4.38 (1.38) in 108 and 107 participants, respectively, for which p = 5.07 9 10 À12 , 10 orders of magnitude smaller than the reported p = 0.042 [48].”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [48] source
Not checked in the free run.
- Premisecitation
Each study claimed ethics committee approval from the University of L'Aquila, but this appears to be untrue.
“Each study claimed to have ethics committee approval from the University of L'Aquila, but this appears to be untrue [71,72].”
Quote in the paperSubstantial claim0 of 2 sources checked- cites [71]
Not checked in the free run.
- cites [72]
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- Interpretationown data
The findings cast doubt on the truthfulness of much or all of the group's published output.
“The evidence challenges the veracity of much, if not all, of the published work from this group.”
Quote in the paperSubstantial claim - Interpretationown data
The updated meta-analysis gives similar information to that of others when Schietroma trials are excluded.
“Our updated meta-analysis provides similar information to that of others if the Schietroma trials are excluded in the analysis [9,10].”
Quote in the paperSubstantial claim0 of 2 sources checked - Premisecitation
Liberal oxygen administration raises mortality in acute illness.
“Liberal oxygen administration increases mortality in acute illness [9].”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [9] source
Not checked in the free run.
- Premisecitation
Four of the retracted papers were randomised controlled trials of liberal peri-operative oxygen comparing 80% with 30%.
“Four of these papers were randomised controlled trials of liberal peri-operative oxygen (80% vs. 30%) [1,[3][4][5].”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [1,[3][4][5]
Not checked in the free run.
- Premisecitation
Five papers by Schietroma et al. have been retracted.
“Five papers authored by Schietroma et al. have been retracted [1][2][3][4][5].”
- Also stated in: § Abstract · plain
“Five trials by this group have been retracted for duplication, plagiarism, statistical error and lack of ethical approval.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [1][2][3][4][5]
Not checked in the free run.
- Also stated in: § Abstract · plain
- Premisecitation
A recent meta-analysis found that liberal peri-operative inspired oxygen did not lower surgical site infection when three Schietroma trials were left out.
“Liberal peri-operative inspired oxygen did not reduce surgical site infection when three trials by Schietroma et al. were excluded in a recent meta-analysis [10].”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [10] source
Not checked in the free run.
- Interpretationown data
Schietroma's liberal oxygen trials were markedly different from the pooled results of all other published trials.
“Our meta-analysis indicated that this group's trials of liberal inspired peri-operative oxygen to reduce surgical site infection were markedly different from the pooled results of all other published trials.”
Quote in the paperSubstantial claim - Interpretationown data
When data from all non-Schietroma trials are pooled, they do not support liberal inspired oxygen for lowering surgical site infection rates.
“Pooled data from all trials by authors other than Schietroma et al. do not support the use of liberal inspired oxygen to reduce surgical site infection rates.”
Quote in the paperSubstantial claim - Interpretationown data
The authors found extensive evidence supporting an investigation into Schietroma's work.
“We found extensive evidence to support an investigation into work by Mario Schietroma's group.”
Quote in the paperSubstantial claim
- May combine two claims. 7
- Classified as probably not a substantial claim. 4
- The quote only partly states this claim. 1
May combine two claims.
Findingown dataThe terminal digit was even for 149 of 184 (81%) p values, differing from the expected 83 of 184 (p = 3.0 × 10^-12) and from an equal odd/even split of 92 of 184 (p = 1.1 × 10^-9).
“The terminal (right-hand) digit was even (0, 2, 4, 6 or 8) for 149/184 (81%) p values, reported to one digit (83), for two digits (91) or three digits(10); this rate was different to the expected rate of 83/184, p = 3.0 9 10 À12 and different to an equal number of odd and even terminal digits, 92/184, p = 1.1 9 10 À9 .”
Quote in the paperSubstantial claimMay combine two claims.
Findingown dataSchietroma's trials were more consistent than expected, each reporting more than a 50% reduction in outcome with liberal oxygen.
“In short, the Schietroma trials were more consistent in their results than one would expect, with each reporting more than a 50% reduction in outcome when using liberal inspired oxygen.”
Quote in the paperSubstantial claimClassified as probably not a substantial claim.
Findingown dataIn 40 papers authored by Mario Schietroma, 184 p values were calculated.
“The cumulative distribution of 184 p values, calculated for 40 papers with Mario Schietroma as an author”
Quote in the paperSubstantial claimMay combine two claims.
Findingown dataThe authors included 20 other randomised trials of liberal peri-operative inspired oxygen, with 8357 participants.
“We included 20 other randomised trials of liberal peri-operative inspired oxygen in 8357 participants”
Quote in the paperSubstantial claimMay combine two claims. The quote only partly states this claim.
Findingnone givenContinuous variables were sometimes heterogeneous between groups within studies, but their distribution varied little between studies.
“The groups within trials were often imbalanced, particularly for neutrophil count, but their distribution was relatively homogeneous.”
Quote in the paperNot a substantial claimMay combine two claims.
Findingown dataVariation between studies was low for anastomotic leak (p = 0.000006), ASEPSIS score < 19 (p = 0.012), and wound infection (p < 1 × 10^-7).
“The probabilities for variation between studies for some categorical outcomes were: anastomotic leak, p = 0.000006; ASEPSIS score < 19, p = 0.012; and wound infection, p < 1 9 10 À7 (see Supporting Information Figures S1-S6).”
Quote in the paperSubstantial claimMay combine two claims.
Findingown dataThe authors identified 40 papers meeting their criteria: 24 randomised controlled trials with 5064 participants and 16 observational studies with 1847 patients.
“We analysed 40 papers by this group: 24 randomised controlled trials (5064 participants) and 16 observational studies (1847 patients).”
- Also stated in: § Results · plain
“We identified 40 papers that fulfilled our criteria [1-5, 16-50]: 24 randomised controlled trials with 5064 participants Data S1)).”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [1-5, 16-50]
Not checked in the free run.
- Also stated in: § Results · plain
Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
Study design and conductnone givenLimitations include those inherent in the Carlisle method and in meta-analysis.
“Limitations of our paper include those inherent in the Carlisle method and in meta-analysis.”
Quote in the paperNot a substantial claimClassified as probably not a substantial claim.
PremisecitationWhether liberal peri-operative inspired oxygen is beneficial has been contested.
“The merits of liberal peri-operative inspired oxygen have been disputed [7,8].”
Quote in the paperSubstantial claim0 of 2 sources checkedClassified as probably not a substantial claim.
PremisecitationIn 2016, the World Health Organization strongly recommended that adults having general anaesthesia with endotracheal intubation for surgery receive 80% inspired oxygen during operation and, if feasible, for 2-6 hours after operation to lower surgical site infection risk.
“In 2016, the World Health Organization made a strong recommendation that “adult patients undergoing general anaesthesia with endotracheal intubation for surgical procedures should receive an 80% fraction of inspired oxygen intra-operatively and, if feasible, in the immediate postoperative period for 2-6 h to reduce the risk of surgical site infection.”[6]”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [6]
Not checked in the free run.
The paper relies on this without support.
The 2016 WHO recommendation was based on a meta-analysis of 15 randomised controlled trials, two of which were by Schietroma's group.
“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.”
The paper relies on this without support.
The WHO has updated its guideline and excluded trials by Schietroma et al.
“The WHO has recently updated their guideline, and excluded trials by Schietroma et al.”
“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.”
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
SPRITE reconstructs potential discrete data sets using the mean, standard deviation, sample size, and lower and upper bounds of item values.
“SPRITE (Sample Parameter Reconstruction via Iterative Techniques) is a technique for reconstructing potential discrete data sets using basic summary information about a sample, namely the mean, the SD, the sample size, and the lower and upper bounds of the range of item values.22”
From Assessing Research Misconduct in Randomized Controlled Trials (2021) · cites this paper as [22]
SPRITE complements GRIMMER, has no sample-size limitation, can handle per-cell sample sizes in the thousands, and considers the range of possible raw values.
“SPRITE complements GRIMMER tests.It does not have a sample size limitation and can be used with per-cell sample sizes in the thousands.SPRITE also takes into consideration the range of possible values of the raw data.”
From Assessing Research Misconduct in Randomized Controlled Trials (2021) · cites this paper as [22]
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Flagged first, then by citations
Research works printed but not linked: 3
- Piccirillo JF, 2018, Dexamethasone for the Prevention of Recurrent Laryngeal Nerve Palsy and Other Complications After Thyroid Surgery: A Randomized Double‐blind Placebo‐Controlled Trial, Journal of the American Medical Association Otolaryngology – Head and Neck Surgery, 144, 1089
- 2017, Retraction notice to “How Does High‐Concentration Supplemental Perioperative Oxygen Influence Surgical Outcomes after Thyroid Surgery? A Prospective, Randomized, Double‐Blind, Controlled, Monocentric Trial, Journal of the American College of Surgeons, 225, 359
- Retraction Watch.JAMA journal retracts paper when author can’t produce original data.2018;https://retractionwatch.com/2018/10/25/jama-journal-retracts-paper-when-author-cant-produce-original-data/(accessed 26/10/2018).
Cited by
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Integrity of randomized controlled trials: challenges and solutions
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Dissemination of medical publications on social media – is it the new standard?
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Assessing Research Misconduct in Randomized Controlled Trials
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Benefits and harms of increased inspiratory oxygen concentrations
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Oxygen therapy for critically Ill and post-operative patients
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Medical science faces the post-truth era: a plea for the grassroot values of science
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How a data detective exposed suspicious medical trials.
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Assessing the scientific integrity of the collected work of one author or author group
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Perioperative oxygen therapy: an overview of systematic reviews and meta-analyses
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Perioperative oxygenation—what's the stress?
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Self-citationBillings, F. T., McIlroy, D. R., Shotwell, M. S., Lopez, M. G., Vaughn, M. T., Morse, J. L., Hennessey, C. J., Wanderer, J. P., Semler, M. W., Rice, T. W., et al. (2024) · Anesthesiology · doi:10.1097/aln.0000000000005078 · Cited by 9 · see citing works
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Pro-Con Debate: Interdisciplinary Perspectives on Industry-Sponsored Research
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Perioperative oxygen therapy: meaningful outcomes and unintended consequences?
Grocott, M. P. W., Miller, T. E., Mythen, M. G., & Martín, D. (2019) · British Journal of Anaesthesia · doi:10.1016/j.bja.2019.03.035 · Cited by 8 · see citing works
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Supplemental Oxygen and the Risk of Surgical Site Infection
Hovaguimian, F., Elia, N., & Tramèr, M. R. (2019) · Anesthesiology · doi:10.1097/aln.0000000000002897 · Cited by 7 · see citing works
Pro-Con Debate: Interdisciplinary Perspectives on Industry-Sponsored Research
Sessler, D. I., Alman, B. A., Treggiari, M. M., & Mont, M. A. (2023) · Anesthesia & Analgesia · doi:10.1213/ane.0000000000006386 · Cited by 6 · see citing works
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Self-citationWhere to from here with recommendations for perioperative oxygen therapy?
Frei, D. R., & Young, P. J. (2020) · Anaesthesia Critical Care & Pain Medicine · doi:10.1016/j.accpm.2020.07.022 · Cited by 5 · see citing works
Effectiveness of antenatal corticosteroids at term: Can we trust the data that ‘inform’ us?
Mol, B. W., Li, W., Lai, S., & Stock, S. J. (2021) · European Journal of Obstetrics & Gynecology and Reproductive Biology · doi:10.1016/j.ejogrb.2021.04.031 · Cited by 5 · see citing works
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Trustworthiness assessment of published clinical trials: Literature review of domains and questions
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Surgical Infection Society Research Priorities: A Narrative Review of Fourteen Years of Progress
Mele, T. S., Kaafarani, H. M. A., Guidry, C. A., Loor, M. M., Machado-Aranda, D., Mendoza, A. E., Morris‐Stiff, G. J., Rattan, R., Schubl, S. D., & Barie, P. S. (2020) · Surgical Infections · doi:10.1089/sur.2020.309 · Cited by 4 · see citing works
Perioperative Oxygenation Targets in Adults
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CON : Routine hyperoxygenation in adult surgical patients whose tracheas are intubated
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Is there clarity on the horizon for peri‐operative oxygen therapy?
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Oxygen Therapy during Surgery: Decisions Need Reliable Data
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The role of hyperoxia in cardiac enhanced recovery programs
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The Impact Of Perioperative Oxygen Regimens On Recovery After Major Surgery
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Oxygen Concentration during Induction and Maintenance of Anesthesia
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Fraction of inspired oxygen in thoracic surgery: how much is too much?
Gorky, J. M., de Lima, A., & Popescu, W. M. (2025) · Current Opinion in Anaesthesiology · doi:10.1097/aco.0000000000001597
Cumpstey, A. F., Stygall, J., Clark, A. D., Minnion, M., Moyses, H., Martin, D. S., Edwards, M. R., Feelisch, M., & Grocott, M. P. W. (2026) · Anaesthesia Reports · doi:10.1002/anr3.70109
- Authors
- Myles, P. S., Carlisle, J. B., & Scarr, B.
- Affiliations
- The Alfred Hospital (AU)
- Torbay Hospital (GB)
- The Royal Melbourne Hospital (AU)
- Corresponding author
- Myles, P. S.
- Venue
- Anaesthesia
- Publisher
- Wiley
- Published
- 2019-02-17
- Volume
- 74
- Issue
- 5
- Pages
- 573-584
- ISSN
- 0003-2409 (ISSN-L)
- 1365-2044
- OpenAlex
- W2915437227
- Cited by
- 64
- References
- 66
- Citations by year
- 2026: 1 · 2025: 4 · 2024: 9 · 2023: 9 · 2022: 11 · 2021: 10 · 2020: 6 · 2019: 14
- FWCI
- 2.72
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Anaesthesia (publishedVersion)
- PubMed (publishedVersion)
- Monash University Research Portal (Monash University) (submittedVersion, other-oa)
- Topics
- Social Sciences › Safety Research › Academic integrity and plagiarism
- Physical Sciences › Mathematics › Statistics and Probability › Benford’s Law and Fraud Detection
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Keywords
- data integrity, research misconduct, surgical site infection, intraoperative mechanical ventilation, statistical errors, HLA-DR, meta-analysis critique
- MeSH terms
- Humans, Oxygen Inhalation Therapy, Surgical Wound Infection, Scientific Misconduct, Randomized Controlled Trials as Topic, Perioperative Care, Biomedical Research, Observational Studies as Topic
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Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
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