Rigor Reviewed

Rigor-Reviewed Manuscript

Intraoperative Driving Pressure-Guided High PEEP vs Standard Low PEEP for Postoperative Pulmonary Complications.

Name: Αlpha¹ Rigor Record — Intraoperative Driving Pressure-Guided High PEEP vs Standard Low PEEP for Postoperative Pulmonary Complications.
Item: Intraoperative Driving Pressure-Guided High PEEP vs Standard Low PEEP for Postoperative Pulmonary Complications.
Rating: 96
Author: Αlpha¹

Writing and Steering Committees for the DESIGNATION–Investigators, Dorland G, Gama de Abreu M, Hemmes SNT, Hol L, Hollmann MW, van Meenen DMP, Nijbroek SGLH, Schultz MJ, Serpa Neto A, Vermeulen TD

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Αlpha¹ Rigor Review — 4★ (Strong), 0 critical, 3 high issues for “Intraoperative Driving Pressure-Guided High PEEP vs Standard Low PEEP for Postoperative Pulmonary Complications.”

Links back to this Rigor Record.

Αlpha¹ Editorial

This rigor review was examined and confirmed by Αlpha¹ Editorial · August 15, 2026

Αlpha¹ Rigor Review

Rigor Reviewed

4 / 5

Strong — minor issues to address

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

IntegrityIntegrity concern−0.5★
ReportingData & code availability partially met−0.25★
CitationsUnresolved reference−0.25★

Model-reported confidence: highReviewer agreement: highEngine: 7.39.0Source: full text

Not verified in this report

No data or code availability links were detected to verify.

Problems surfaced3 types

Numerical inconsistencies1

Values that contradict each other or are impossible for the stated sample: recomputed p-values and test statistics, GRIM/GRIMMER checks on summary numbers, percentages against their own counts, totals against their parts, and estimates against their own confidence intervals.

Internal contradictions in the reported numbersAssessed

Reporting gaps1

Required detail the manuscript never states — study design, biological variables, ethics approval and consent, key resources, statistical reporting, data and code availability, and overall transparency.

Data/code availability incompleteAssessed

Broken references and links1

References checked against Crossref, OpenAlex and Retraction Watch for retractions and resolvability, plus declared data and code links probed for whether they resolve to content matching the paper.

References not resolvable to a published paperRecomputed

This Αlpha¹ Rigor Review uses AI Rigor Reviewers trained on a curated corpus of high-fidelity and retracted papers, with expert supervision and curation. It can still make mistakes; verify each finding against the source before relying on it.

This is a well-conducted, well-reported multicenter randomized trial with rigorous design, clear ethics, and transparent reporting. The main weakness is the vague data sharing statement, and there are minor copyedit inconsistencies in Figure 1 and the abstract.

Both reviewers independently scored all eight dimensions and agreed on every status; no divergence to reconcile. The statistics verification recomputed only 1 reported test (consistent), so the broader statistical analysis is not fully machine-verified. The citation check flagged 1 reference not found in any registry.

7 major claims checked against the paper's own evidence: all adequately supported.

Recomputed 1 test: 1 consistent, 0 inconsistent; 1 via agent-written checks.

1 integrity concern flagged (0 high).

Reporting

Eight Dimensions7 pass · 1 warn

The introduction cites prior trials on lung-protective ventilation, PEEP, and driving pressure, and notes limitations of previous individualized PEEP trials (complex designs, bundled interventions). The rationale linking driving pressure to outcomes and the need for a trial isolating intraoperative PEEP titration is clearly stated.

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

The paper establishes a clear scientific premise with prior work cited, a logical rationale, and acknowledgment of limitations in prior research.

Evidence

paraphrase[Introduction, paragraph 2]

“However, later trials isolating PEEP—while maintaining low tidal volumes—showed no clear benefit.”

paraphrase[Introduction, paragraph 3]

“The Driving Pressure During General Anesthesia for Open Abdominal Surgery (DESIGNATION) trial was conducted to test whether an intraoperative ventilation strategy with an individualized, driving pressure–guided, high level of PEEP and recruitment maneuvers reduced the incidence of postoperative pulmonary complications...”

paraphrase[Introduction, paragraph 2]

“Two recent trials evaluated individualized PEEP strategies, but complex designs, including postoperative care or bundled interventions, limit conclusions about intraoperative PEEP titration alone.”

PASSReviewer 2· 95% conf

The paper establishes a clear scientific premise by citing prior trials and explaining the rationale for the study.

Evidence

paraphrase[Introduction, paragraph 2]

“However, later trials isolating PEEP—while maintaining low tidal volumes—showed no clear benefit.”

direct quote[Introduction, paragraph 2]

“Driving pressure, a marker of lung strain, is independently associated with postoperative pulmonary complications.”

paraphrase[Introduction, paragraph 2]

Randomization used a computer-generated allocation sequence with permuted block sizes and stratification by site and BMI. Blinding of outcome assessors was implemented. A priori power analysis was provided. Inclusion/exclusion criteria were detailed. The analysis population (primary analysis population) and per-protocol analysis were defined, addressing missing data and dropouts.

Sub-criteria

controlsN/A

power analysisADEQUATE

blinding levelsADEQUATE

outlier handlingADEQUATE

randomization unitADEQUATE

inclusion exclusionADEQUATE

randomization methodADEQUATE

replicate distinctionN/A

independent replicationN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

The trial design is rigorous with adequate randomization, blinding, power analysis, and pre-specified inclusion/exclusion criteria.

Evidence

paraphrase[Methods, Randomization and Interventions]

“A computer-generated allocation sequence using permuted random block sizes of a maximum of 8 and stratified per study site and BMI (≤30 vs >30) was used.”

paraphrase[Methods, Blinding]

“At every center, at least 2 investigators obtained patient data: one investigator was aware of the patient allocation and obtained intraoperative data, the other remained blinded to the intraoperative interventions and assessed outcomes.”

paraphrase[Methods, Statistical Analysis]

“Assuming a rate of postoperative pulmonary complications of 34% in the low PEEP group and a dropout rate of 2%, an enrollment of 1468 patients would provide 80% power to detect a relative risk reduction of 20% for the incidence of postoperative pulmonary complications at a 2-sided α level of .05.”

PASSReviewer 2· 95% conf

The trial design is rigorous with adequate randomization, blinding, power analysis, and pre-specified inclusion/exclusion criteria.

Evidence

paraphrase[Methods, Randomization and Interventions]

“A computer-generated allocation sequence using permuted random block sizes of a maximum of 8 and stratified per study site and BMI (≤30 vs >30) was used.”

paraphrase[Methods, Blinding]

paraphrase[Methods, Statistical Analysis]

The paper reports age, sex, weight, BMI, ARISCAT score, ASA status, functional status, coexisting disorders, smoking status, and procedure types in Table 1. Both sexes are included, so sex justification is not applicable. Species/strain and housing conditions are not applicable for a human trial.

Sub-criteria

demographicsADEQUATE

sex reportedADEQUATE

sex justifiedN/A

age weight healthADEQUATE

housing conditionsN/A

species strain sourceN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

Demographic and clinical characteristics are well reported, including age, sex, weight, BMI, and comorbidities.

Evidence

direct quote[Table 1]

“Female 360 (50.1) 390 (54.4)”

direct quote[Table 1]

“Age, median (IQR), y 66.0 (57.0-73.0) 65.0 (57.0-73.0)”

direct quote[Table 1]

“Coexisting disorders Diabetes 84 (11.7) 85 (11.9)”

PASSReviewer 2· 95% conf

Demographic and clinical characteristics are well reported, including sex, age, weight, and comorbidities.

Evidence

paraphrase[Results, Patients]

“52% female”

direct quote[Results, Patients]

“patients were a median (IQR) age of 66 (57-74) years”

direct quote[Table 1]

“Diabetes 84 (11.7) 85 (11.9)”

The study was approved by the institutional review board of Amsterdam University Medical Centers, and written informed consent was obtained from all participants. The trial was registered and conducted per CONSORT guidelines.

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

Ethical approval and informed consent are clearly documented.

Evidence

direct quote[Methods, Study Design and Oversight]

“The study was approved by the institutional review board of Amsterdam University Medical Centers, Academic Medical Center location.”

direct quote[Methods, Study Design and Oversight]

“Written informed consent was obtained from all participants.”

direct quote[Methods, Study Design and Oversight]

“The trial was conducted and reported according to the Consolidated Standards of Reporting Trials (CONSORT) guidelines.”

PASSReviewer 2· 95% conf

Ethical approval and informed consent are clearly documented.

Evidence

direct quote[Methods, Study Design and Oversight]

“The study was approved by the institutional review board of Amsterdam University Medical Centers, Academic Medical Center location.”

direct quote[Methods, Study Design and Oversight]

“Written informed consent was obtained from all participants.”

direct quote[Methods, Study Design and Oversight]

“The trial was conducted and reported according to the Consolidated Standards of Reporting Trials (CONSORT) guidelines.”

The trial uses a non-pharmacological intervention (ventilation strategy) with detailed protocol descriptions. No drugs, biologics, or devices are used as investigational products. Statistical software (R version 4.3.3) is identified. Other resource criteria are not applicable.

Sub-criteria

mycoplasma testingN/A

reagents identifiedN/A

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The investigational intervention (ventilation strategy) is described in detail, and statistical software is identified.

Evidence

direct quote[Methods, Statistical Analysis]

“Analyses were performed using R version 4.3.3 (R Foundation).”

PASSReviewer 2· 90% conf

The investigational intervention (PEEP strategy) is adequately described, and statistical software is identified.

Evidence

direct quote[Methods, Statistical Analysis]

“Analyses were performed using R version 4.3.3 (R Foundation).”

The primary analysis used a mixed-effect generalized linear model with binomial distribution and identity link, with site as random effect. P-values are reported as exact values (e.g., P = .23). Effect sizes are reported as absolute differences with 95% CIs. Statistical software is identified. Data presentation includes per-group n and appropriate figures. Mathematical plausibility checks were not applicable due to large N and continuous outcomes.

Sub-criteria

tests namedADEQUATE

exact p valuesADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedADEQUATE

assumptions verifiedADEQUATE

mathematical plausibilityN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Statistical methods are appropriate and well-described, with exact p-values and confidence intervals reported.

Evidence

direct quote[Methods, Statistical Analysis]

“The effect of high PEEP compared with low PEEP on the incidence of postoperative pulmonary complications was assessed using a mixed-effect generalized linear model with binomial distribution and identity link.”

direct quote[Results, Outcomes]

“absolute difference, 2.5% [95% CI, −1.5% to 6.4%]; P = .23”

direct quote[Results, Outcomes]

“absolute difference, 2.5% [95% CI, −1.5% to 6.4%]”

PASSReviewer 2· 90% conf

Statistical methods are appropriate and well-described, with exact p-values and confidence intervals.

Evidence

direct quote[Methods, Statistical Analysis]

paraphrase[Results, Outcomes]

“P = .23”

direct quote[Results, Outcomes]

“absolute difference, 2.5% [95% CI, −1.5% to 6.4%]”

The paper mentions a Data Sharing Statement in Supplement 6, but the specific content is not provided in the text. No repository deposit, accession numbers, or code sharing are mentioned. For a clinical trial, managed access is acceptable, but the statement is not detailed in the main text.

Sub-criteria

code sharingNOT REPORTED

accession numbersN/A

repository depositNOT REPORTED

data availability statementINADEQUATE

Per reviewer (2) — the votes behind the verdict

WARNReviewer 1· 80% conf

A data sharing statement is present but vague, and no repository or code is provided.

Evidence

direct quote[Article Information]

“Data Sharing Statement: See Supplement 6.”

WARNReviewer 2· 80% conf

A data sharing statement is present but vague, and no repository or code is provided.

Evidence

direct quote[Article Information]

“Data Sharing Statement: See Supplement 6.”

The trial is registered (NCT03884543). Methods are detailed. CONSORT guidelines are followed. All outcomes are reported, including non-significant ones. Limitations are explicitly discussed. Funding and conflicts of interest are disclosed.

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineADEQUATE

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

The manuscript is transparent with complete methods, trial registration, CONSORT adherence, and discussion of limitations.

Evidence

direct quote[Abstract, Trial Registration]

“TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT03884543”

paraphrase[Discussion, Limitations]

“This study has limitations. First, the composite primary outcome included postoperative pulmonary complications of varying severity.”

direct quote[Article Information]

“Funding/Support: This study was supported by a research grant from ZonMw (852001922).”

PASSReviewer 2· 95% conf

The manuscript is transparent with complete methods, trial registration, CONSORT adherence, and discussion of limitations.

Evidence

direct quote[Abstract]

“TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT03884543”

direct quote[Methods, Study Design and Oversight]

“The trial was conducted and reported according to the Consolidated Standards of Reporting Trials (CONSORT) guidelines.”

paraphrase[Discussion, Limitations]

“This study has limitations. First, the composite primary outcome included postoperative pulmonary complications of varying severity.”

4 copyedit issues flagged: mostly typo, consistency.

Checked 26 references by DOI: 25 verified — 1 DOI unresolved.

Reproducibility

Registered (1 ID: ClinicalTrials.gov). Reporting guideline cited: CONSORT.

Αlpha¹ Rigor Action ItemsFinal pass before journal submission

The published work is methodologically robust and transparent; an informed reader should weigh the minor reporting gaps (vague data sharing statement, Figure 1 number inconsistencies) and the one unresolved reference. No erratum is warranted for the rigor dimensions, but the Figure 1 discrepancies should be corrected.

1.
HIGHdata code
In the Data Sharing Statement (Article Information / Supplement 6), specify the data access mechanism (e.g., data access committee, conditions, timeline, contact) instead of only referencing Supplement 6.
A vague data sharing statement is a reporting gap that limits reproducibility and is the only non-pass dimension.
2.
HIGHdata code
Deposit the statistical analysis code in a public repository (e.g., Zenodo) with a DOI and include the link in the Data Sharing Statement.
Providing code enhances reproducibility and addresses the 'code_sharing' not_reported gap.
3.
HIGHother
Verify or correct the reference 'Effect of lung protection mechanical ventilation on respiratory function in the elderly undergoing spinal fusion (in Chinese)' (DOI 10.3969/j.issn.1672-7347.2013.01.015), which was not found in any registry.
An unresolved reference may be fabricated or contain an incorrect DOI; it must be verified or replaced.
4.
MEDIUMcopyedit
In Figure 1 legend, correct the number randomized to high PEEP from 734 to 718 to match the text and Table 1.
The internal contradiction between the figure and text undermines data integrity and reader trust.
5.
MEDIUMcopyedit
In Figure 1 legend, correct the number randomized to low PEEP from 734 to 717 to match the text and Table 1.
Same as above; the figure must be consistent with the reported numbers.
6.
MEDIUMcopyedit
In Figure 1 legend, remove the stray 'a' in 'ARISCAT a score <26' or format it as a proper footnote marker.
This is a typographical error that could confuse readers.
7.
MEDIUMcopyedit
In the Abstract and Results, ensure the denominator for the primary analysis is consistently stated (e.g., 'randomized' vs 'included in primary analysis').
Inconsistent denominators between abstract and results can mislead readers about the analysis population.
8.
LOWdata code
If any non-identifiable aggregate data are available, deposit them in a public repository and provide an accession number in the Data Sharing Statement.
This would strengthen the data availability statement beyond a mere reference to a supplement.

Full text (46,886 chars)Analyzed: Aug 15, 2026

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