Rigor Reviewed

Rigor-Reviewed Manuscript

Proactive vs Reactive Treatment of Hypotension During Surgery: The PRETREAT Randomized Clinical Trial.

Name: Αlpha¹ Rigor Record — Proactive vs Reactive Treatment of Hypotension During Surgery: The PRETREAT Randomized Clinical Trial.
Item: Proactive vs Reactive Treatment of Hypotension During Surgery: The PRETREAT Randomized Clinical Trial.
Rating: 96
Author: Αlpha¹

Kant M, van Klei WA, Hollmann MW, de Klerk ES, Otterspoor LC, Besselink MG, Kappen TH, Veelo DP, PRETREAT study group

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Αlpha¹ Rigor Review — 4.25★ (Strong), 0 critical, 3 high issues for “Proactive vs Reactive Treatment of Hypotension During Surgery: The PRETREAT Randomized Clinical Trial.”

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

4.25 / 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★

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

Not verified in this report

Statistics were not checked: no recomputable values were found in this text — no test statistic reported with its degrees of freedom, no effect estimate printed with both a 95% CI and a p-value, and no percentage printed with both its count and its denominator.
The numeric-impossibility checks (GRIM/GRIMMER/DEBIT/SPRITE) did not run: 8 reported means were read, and their group size is not stated where the values are printed (this source has no machine-readable table structure). These checks need the count the mean was averaged over, so none was performed.
No data or code availability links were detected to verify.

Problems surfaced2 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

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 and well-reported randomized clinical trial with rigorous design, clear ethics approval, and transparent reporting. The main weakness is the vague data availability statement, which lacks a concrete repository or access mechanism.

Both reviewers independently scored all eight dimensions and agreed on all statuses. The study type is interventional (RCT). Non-applicable sub-criteria (e.g., animal housing, cell lines) were excluded. The statistics verification component checked 0 tests, so no statistical errors were found, but this does not confirm the correctness of unreported analyses.

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

1 integrity concern flagged (0 high).

Reporting

Eight Dimensions7 pass · 1 warn

The introduction cites prior studies on intraoperative hypotension and notes their limitations (small sample sizes, failure to achieve blood pressure differences). The rationale for risk-stratified MAP targets is clearly linked to the hypothesis. The paper does not explicitly describe how limitations of prior research are addressed beyond the design features mentioned in the discussion.

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedINADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The paper establishes a clear scientific premise with prior work cited and a logical rationale for the hypothesis.

Evidence

paraphrase[Introduction, paragraph 1]

“Several randomized trials have been conducted, although they were limited by small sample sizes, or failure to report or achieve substantial differences in blood pressures between intervention and control groups.”

paraphrase[Introduction, paragraph 2]

“Based on this rationale, we hypothesized that stratified blood pressure targets—adjusted to a patient’s expected risk of intraoperative hypotension—could reduce intraoperative hypotension and improve outcomes.”

paraphrase[Discussion, paragraph 5]

“Paraphrase: The discussion lists design features that address prior trial limitations, but the introduction does not explicitly state how limitations are mitigated.”

PASSReviewer 2· 90% conf

The paper establishes a clear scientific premise with prior work cited and a logical rationale for the study hypothesis.

Evidence

paraphrase[Introduction, paragraph 1]

paraphrase[Introduction, paragraph 2]

Randomization used concealed computer-generated permuted blocks, stratified by risk. Blinding was partial: patients and outcome assessors were blinded, but treating anesthesiologists were not (unavoidable). Power analysis was performed with a prespecified MCID and sample size. Inclusion/exclusion criteria were clearly defined. Outlier handling is addressed through the analysis population and missing data imputation. Controls are appropriate (usual care). Independent replication is not applicable for a single pivotal trial.

Sub-criteria

controlsADEQUATE

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 inclusion/exclusion criteria.

Evidence

paraphrase[Methods, Trial Procedures]

“Patients were randomized 1:1 to a proactive blood pressure management strategy (intervention) or usual care (control), using concealed, computer-generated permuted blocks (sizes 4, 6, 8) in Castor EDC software, stratified by predicted intraoperative hypotension risk.”

paraphrase[Methods, Trial Procedures]

“Patients were not informed of their allocation until after completion of the 6-month follow-up questionnaires to avoid influencing self-reported outcomes. Treating anesthesiologists in the intervention group were aware of allocation to deliver the proactive strategy, whereas anesthesiologists in the control group were not informed that their patients were participating in the trial to minimize changes in usual care behavior.”

paraphrase[Methods, Sample Size Calculation and Power]

“Accounting for an anticipated 20% loss to follow-up at 6 months, we estimated that a total of 2500 patients per group would provide sufficient power (eAppendix 2 in Supplement 2).”

PASSReviewer 2· 95% conf

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

Evidence

paraphrase[Methods, Trial Procedures]

direct quote[Methods, Trial Procedures]

“patients completed outcome questionnaires digitally, ensuring that outcome assessment remained blinded to treatment allocation.”

paraphrase[Methods, Sample Size Calculation and Power]

“Accounting for an anticipated 20% loss to follow-up at 6 months, we estimated that a total of 2500 patients per group would provide sufficient power”

Sex is reported for both groups. Age and health status (ASA classification, comorbidities) are reported. Demographics include age, sex, and comorbidities. Species/strain and housing are not applicable. Sex justification is not applicable because both sexes were enrolled.

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· 90% conf

Sex, age, and health status are reported; demographics are adequate for a human trial.

Evidence

direct quote[Table 1]

“Sex, No. (%) Men 764 (47.2) 745 (45.7) Women 854 (52.8) 884 (54.3)”

direct quote[Table 1]

“Age, median (IQR), y 59 (44-69) 59 (45-69)”

direct quote[Table 1]

“Preexisting conditions, No. (%) a Hypertension 470 (29.0) 480 (29.5)”

PASSReviewer 2· 90% conf

Demographic and clinical characteristics are well reported, including sex, age, and health status.

Evidence

direct quote[Table 1]

“Age, median (IQR), y 59 (44-69) 59 (45-69) Sex, No. (%) Men 764 (47.2) 745 (45.7) Women 854 (52.8) 884 (54.3)”

The trial was approved by a named ethics committee (Medical Ethics Committee of the University Medical Center Utrecht, reference No. 20-749). Written informed consent was obtained from all participants. Regulatory compliance is implied through adherence to CONSORT and Dutch regulations, though not explicitly named.

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceINADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

Ethics approval and informed consent are clearly documented.

Evidence

direct quote[Methods, Design, Organization, and Oversight]

“The trial protocol was approved by the Medical Ethics Committee of the University Medical Center Utrecht (reference No. 20-749) and has been published previously (Supplement 1).”

paraphrase[Methods, Design, Organization, and Oversight]

“All participants provided written informed consent before enrollment.”

absence[Methods, Design, Organization, and Oversight]

Regulatory compliance not explicitly named.

PASSReviewer 2· 95% conf

Ethical approval and informed consent are clearly documented.

Evidence

direct quote[Methods, Design, Organization, and Oversight]

“The trial protocol was approved by the Medical Ethics Committee of the University Medical Center Utrecht (reference No. 20-749)”

paraphrase[Methods, Design, Organization, and Oversight]

“All participants provided written informed consent before enrollment.”

The intervention is a clinical strategy, not a drug or device, but the MAP targets and vasopressor use are described. Software (Castor EDC, R, brms) is identified. No antibodies, cell lines, or organisms are used, so those are not applicable.

Sub-criteria

mycoplasma testingN/A

reagents identifiedADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 85% conf

The investigational product (blood pressure management strategy) is described, and software is identified.

Evidence

paraphrase[Methods, Trial Procedures]

“The intervention strategy required anesthesiologists to maintain a minimum intraoperative MAP of at least 65 mm Hg, with goals of at least 70 mm Hg for low-risk, at least 80 mm Hg for intermediate-risk, or at least 90 mm Hg for high-risk patients.”

direct quote[Methods, Statistical Analysis]

“Markov Chain Monte Carlo sampling was performed in R with the brms package (via Stan).”

PASSReviewer 2· 85% conf

The investigational product (blood pressure management strategy) is adequately described, and software tools are identified.

Evidence

direct quote[Methods, Statistical Analysis]

“Markov Chain Monte Carlo sampling was performed in R with the brms package (via Stan).”

paraphrase[Methods, Trial Procedures]

All tests are named (Bayesian linear/logistic regression). Assumptions are handled through Bayesian modeling with weakly informative priors. Exact p-values are not reported; instead, credible intervals and posterior probabilities are used, which is appropriate for Bayesian analysis. Effect sizes are reported with credible intervals. Software is identified. Data presentation includes per-group n and dispersion. Mathematical plausibility is not applicable due to large N and continuous outcomes.

Sub-criteria

tests namedADEQUATE

exact p valuesN/A

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; reporting uses credible intervals and Bayesian methods.

Evidence

direct quote[Methods, Statistical Analysis]

“All analyses were conducted using a bayesian framework, which allowed us to estimate credible treatment effects given the observed data.”

direct quote[Results, Primary Outcome]

“The between-group difference was –0.5% (95% CrI, –1.9% to 0.9%)”

direct quote[Methods, Statistical Analysis]

“Markov Chain Monte Carlo sampling was performed in R with the brms package (via Stan).”

PASSReviewer 2· 90% conf

Statistical methods are appropriate and well-described, with Bayesian analyses and credible intervals.

Evidence

direct quote[Methods, Statistical Analysis]

“All analyses were conducted using a bayesian framework, which allowed us to estimate credible treatment effects given the observed data.”

direct quote[Results, Primary Outcome]

“The between-group difference was –0.5% (95% CrI, –1.9% to 0.9%)”

The paper states 'Data Sharing Statement: See Supplement 4.' This is vague and does not specify a concrete access route. No repository deposit or accession numbers are provided. Code sharing is not mentioned.

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

Data availability statement is vague; no repository deposit or accession numbers.

Evidence

direct quote[End of article]

“Data Sharing Statement: See Supplement 4.”

absence[End of article]

No repository deposit mentioned.

absence[End of article]

No code sharing mentioned.

WARNReviewer 2· 80% conf

Data availability statement is vague, and no repository or code sharing is mentioned.

Evidence

direct quote[End of article]

“Data Sharing Statement: See Supplement 4.”

The trial is registered (NL-OMON55117). CONSORT guidelines are referenced. All prespecified outcomes are reported, including negative results. Limitations are discussed in detail. Conclusions are proportional to the evidence. 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· 90% conf

Reporting is complete with trial registration, CONSORT adherence, and transparent outcome reporting.

Evidence

direct quote[Abstract]

“TRIAL REGISTRATION Overview of Medical Research in the Netherlands (CCMO): NL-OMON55117”

paraphrase[Methods, Design, Organization, and Oversight]

“The trial is reported in accordance with the Consolidated Standards of Reporting Trials (CONSORT) guidelines.”

paraphrase[Discussion, Limitations]

“This study has several limitations. First, the stratified MAP targets were based on preoperative intraoperative hypotension risk and may not fully reflect patients’ intraoperative susceptibility, which could have led to heterogeneous effects within risk groups.”

PASSReviewer 2· 90% conf

The trial is registered, reported per CONSORT, and limitations are discussed.

Evidence

direct quote[Abstract and Methods]

“The trial was registered with the Overview of Medical Research in the Netherlands registry (NL-OMON55117, first registration March 3, 2021).”

paraphrase[Methods, Design, Organization, and Oversight]

“The trial is reported in accordance with the Consolidated Standards of Reporting Trials (CONSORT) guidelines.”

paraphrase[Discussion, Limitations]

3 copyedit issues flagged: mostly consistency, typo.

Checked 30 references by DOI: 28 verified — 2 no DOI (shown, not verified).

Reproducibility

Registration stated in text, but no registry ID was detected. Reporting guideline cited: CONSORT.

Αlpha¹ Rigor Action ItemsFinal pass before journal submission

The published work is robust and well-reported. An informed reader should weigh the vague data availability statement as a minor limitation, but it does not undermine the validity of the findings. No erratum or correction appears necessary based on the rigor review.

1.
HIGHdata code
Replace the vague 'Data Sharing Statement: See Supplement 4' with a concrete statement specifying a repository (e.g., Dryad, Zenodo) or a managed-access platform with conditions and timeframe.
A vague data availability statement does not meet reproducibility standards and is a common reviewer concern.
2.
HIGHdata code
Deposit de-identified individual patient data in a public repository with a DOI or accession number, if permitted by consent and ethics.
Providing a direct data access route enhances reproducibility and reader trust.
3.
HIGHdata code
Share custom analysis code in a public repository (e.g., GitHub) with a permanent identifier, and describe the workflow in sufficient detail.
Code sharing is essential for reproducibility of Bayesian analyses.
4.
MEDIUMethics
Explicitly state compliance with a recognized regulatory framework (e.g., Declaration of Helsinki, ICH-GCP) in the Methods section.
While ethics approval is documented, explicit regulatory compliance strengthens the ethics reporting.
5.
MEDIUMcopyedit
Fix the typo 'mean atrial pressure' to 'mean arterial pressure' in the Abstract/Key Points.
Correct terminology is essential for clarity and accuracy.
6.
MEDIUMcopyedit
Clarify the primary outcome presentation: change '–0.5% (95% CrI, –1.9% to 0.9%)' to '–0.5 (95% CrI, –1.9 to 0.9)' if the outcome is a score difference, not a percentage.
Misleading units can confuse readers about the effect size.
7.
MEDIUMcopyedit
Clarify the participant flow statement: change 'Of the 3247 randomized patients who had received the allocated intervention' to 'Of the 3247 patients who received the allocated intervention'.
The original phrasing is ambiguous about whether all randomized patients are included.
8.
LOWreporting
Clarify the discrepancy between the abstract (3247 patients) and results (3522 randomized) by explicitly stating the timing of the futility analysis.
The internal contradiction is explained but should be made explicit to avoid reader confusion.

Full text (52,481 chars)Analyzed: Aug 15, 2026

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