Kaimen Rigor reviewed

Rigor-Reviewed Manuscript

Cardiac output-guided haemodynamic therapy for patients undergoing major gastrointestinal surgery: OPTIMISE II randomised clinical trial.

Name: Kaimen Rigor review — Cardiac output-guided haemodynamic therapy for patients undergoing major gastrointestinal surgery: OPTIMISE II randomised clinical trial.
Item: Cardiac output-guided haemodynamic therapy for patients undergoing major gastrointestinal surgery: OPTIMISE II randomised clinical trial.
Rating: 59
Author: Alpha1

OPTIMISE II Trial Group

Paper source

Read full text (PMC)

Embed this Rigor badge

Kaimen Rigor review — 4.5★ (Strong), 0 critical, 2 high issues for “Cardiac output-guided haemodynamic therapy for patients undergoing major gastrointestinal surgery: OPTIMISE II randomised clinical trial.”

Links back to this Kaimen Rigor review.

Alpha1 Editorial

This rigor review was examined and confirmed by Alpha1 Editorial · August 16, 2026

Read alongside

Cardiac output-guided haemodynamic therapy for patients undergoing major gastrointestinal surgery: OPTIMISE II randomised clinical trial.

OPTIMISE II Trial Group

Read full text (PMC)

DOI

10.1136/bmj-2024-080439

Share this Kaimen Rigor review

Post on X Share on LinkedIn Share via Email

Embed this Rigor badge

<a href="https://alpha1science.com/verify/7dd2308a-731f-46a7-a31a-54a0b6d151e7" target="_blank" rel="noopener">
  <img src="https://alpha1science.com/verify/7dd2308a-731f-46a7-a31a-54a0b6d151e7/badge" alt="Kaimen Rigor review — 4.5★ (Strong), 0 critical, 2 high issues for “Cardiac output-guided haemodynamic therapy for patients undergoing major gastrointestinal surgery: OPTIMISE II randomised clinical trial.”" width="440" height="104" style="max-width:100%;height:auto" />
</a>

Every embed links back to this Kaimen Rigor review.

Record fingerprint

61d57027699bdc4cdb9492fa99b15d2d98c5258d1f43e6c72bb795ace248cf2a

Verify via API

Issued Aug 16, 2026Engine 7.39.0

Alpha1 assesses methodological rigor, not the importance of the findings. See how we calibrate →

Alpha¹ by Kaimen

Fetching the latest research

Kaimen Rigor reviewed

Rigor-Reviewed Manuscript

Cardiac output-guided haemodynamic therapy for patients undergoing major gastrointestinal surgery: OPTIMISE II randomised clinical trial.

OPTIMISE II Trial Group

Paper source

Cardiac output-guided haemodynamic therapy for patients undergoing major gastrointestinal surgery: OPTIMISE II randomised clinical trial.

Read full text (PMC)

Embed this Rigor badge

Links back to this Kaimen Rigor review.

Alpha1 Editorial

This rigor review was examined and confirmed by Alpha1 Editorial · August 16, 2026

Kaimen Rigor review

Kaimen Rigor reviewed

4.5 / 5

Strong — minor issues to address

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

StatisticsPrinted percentage does not match its own count (capped) ×3−0.25★
ReportingData & code availability partially met−0.25★

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

Not verified in this report

The numeric-impossibility checks (GRIM/GRIMMER/DEBIT/SPRITE) did not run: 10 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.

Biggest issues

01Printed percentage does not match its own count
mediumArithmeticrecomputedFull detail
92.6% does not match the reported count 1156/1251
“1156 (92.6)”
Table 2
02Printed percentage does not match its own count
mediumArithmeticrecomputedFull detail
80.5% does not match the reported count 1005/1251
“1005 (80.5)”
Table 2
03Printed percentage does not match its own count
mediumArithmeticrecomputedFull detail
73.1% does not match the reported count 908/1247
“908 (73.1)”
Table 2

Findings by category

101ArithmeticNumerical inconsistencies 02OverreachNone found 03AuthenticityNone found 104DisclosureReporting gaps 05AvailabilityNone found 06Copyedit8 minor suggestions

This Kaimen Rigor review uses Kaimen 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 multicentre randomised controlled trial. The main methodological strengths are the rigorous design, clear reporting of statistical methods, and comprehensive ethical approvals. The primary weakness is the vague data availability statement, which lacks a concrete access mechanism.

Both reviewers classified the study as interventional, and this was adopted. The evaluation covered all eight dimensions; several sub-criteria were not applicable (e.g., animal-related items) and were excluded. The reviewers agreed on all dimensions except for minor discrepancies in key resources (software identification) and reporting transparency (reporting guideline), which were resolved by adopting the more specific evidence.

Numerical inconsistencies

1 finding · worst medium

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.

Printed percentage does not match its own countRecomputed

Recomputed 6 tests: 6 consistent, 0 inconsistent; 1 recomputed directly from the reported test statistics, 5 via agent-written checks. 3 printed percentages that do not match their own count.

Overstated conclusions

None found

Conclusions that reach past what the paper's own results support — including a significance claim that no longer holds when the statistic is recomputed, and efficacy resting on an unvalidated surrogate endpoint.

Checked — nothing surfaced.

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

Data authenticity concerns

None found

An adversarial read for patterns associated with data that may not be genuine: results that look too clean, implausibly large effects, duplicated data or images, and methods that do not match the results reported.

Checked — nothing surfaced.

Reporting gaps

1 finding · worst medium

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

Eight Dimensions7 pass · 1 warn

The introduction cites previous studies and meta-analyses suggesting benefits of cardiac output-guided therapy while acknowledging controversies and limitations such as high risk of bias in older trials. The rationale for targeting postoperative infections is well-articulated, linking the intervention to improved tissue perfusion and inflammatory pathways.

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The study clearly establishes its scientific premise by citing prior work, outlining the rationale for the intervention, and discussing limitations of previous research.

Evidence

“Cardiac output-guided therapy has proved controversial at times, and excessive early pulmonary artery catheter use generated safety concerns.”

Introduction ¶3Find in source

“Our previous studies described the physiological and pharmacological basis of this effect, including the role of low dose inodilators, finding beneficial changes in inflammatory pathways and improved tissue perfusion and oxygenation.”

Introduction ¶2Find in source

“Meta-analyses further suggest a reduction in postoperative infections and other complications, and shorter hospital stays, but they are limited by the inclusion of many older, single centre trials with a high risk of bias.”

Introduction ¶4Find in source

PASSReviewer 2· 90% conf

The paper establishes a clear scientific premise, citing prior work and providing a logical rationale for the trial.

Evidence

Introduction ¶4Find in source

“We hypothesised that this intervention would reduce postoperative infections compared with usual clinical care.”

Introduction ¶4Find in source

Randomisation used minimisation with a random component via a central online service. Blinding of outcome assessors is described, with a note that blinding of participants was not possible. A priori sample size calculation is provided. Inclusion/exclusion criteria are detailed. The analysis population (ITT) and missing-data approach (mean imputation) are defined.

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· 90% conf

The study design is robust, detailing randomisation, blinding, power analysis, and inclusion/exclusion criteria appropriate for a clinical trial.

Evidence

“participants were randomised in a 1:1 ratio by minimisation with a random component (80% probability to be allocated to the group that minimises the between group differences in the minimisation factors), using a central online service, which concealed the allocation sequence.”

Methods ¶1Find in source

“Research staff collecting and assessing clinical outcomes were not involved in the participants’ care and were unaware of study group allocation. Self-assessment of assessor blinding was performed after follow-up visits.”

Methods ¶2Find in source

“We determined that a sample size of 2502 participants (1251 in each group) would allow detection of a reduction in postoperative infection rate within 30 days, from 30% to 24% with >90% power, using a two sided test with significance level α=0.05.”

Statistical analysis ¶1Find in source

PASSReviewer 2· 95% conf

The trial design is rigorous: randomisation method, blinding, power analysis, inclusion/exclusion criteria, and analysis population are all adequately described.

Evidence

MethodsFind in source

“Research staff collecting and assessing clinical outcomes were not involved in the participants’ care and were unaware of study group allocation.”

MethodsFind in source

Statistical analysisFind in source

The study reports the mean age, sex distribution (57% women), BMI, ASA physical status classification, and a detailed list of comorbidities for both intervention and usual care groups. This provides a clear picture of the study population.

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

Demographic and clinical characteristics of participants are comprehensively reported, including age, sex, ASA status, and comorbidities.

Evidence

“In 2498 patients (mean age 74 (standard deviation 6) years, 57% women)”

AbstractFind in source

paraphrase[Table 1]

“Mean (SD) age (years) | 74.0 (6.4) | 73.9 (6.3) | 0.023 | | Women | 714 (57.1) | 718 (57.6) | 0.009 | | Mean (SD) BMI | 27.2 (5.6) | 27.1 (5.2) | 0.024 | | ASA physical status classification*: | | II | 607 (48.5) | 604 (48.4) | 0.002 | | III | 620 (49.6) | 617 (49.5) | 0.002 | | IV | 24 (1.9) | 26 (2.1) | 0.012 | | Comorbidities: | | Chronic obstructive pulmonary disease | 133 (10.6) | 132 (10.6) | 0.002 |”

“Table 1 Baseline characteristics of participants. Values are number (percentage) unless stated otherwise”

Table 1Find in source

PASSReviewer 2· 90% conf

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

Evidence

“Mean age was 74 (standard deviation 6) years and 1432/2498 (57.3%) participants were women.”

Results ¶1Find in source

“Table 1 Baseline characteristics of participants. Values are number (percentage) unless stated otherwise”

Table 1Find in source

The trial protocol was approved by the UK National Research Ethics Service (IRAS ID 209688) and by responsible ethics committees in all participating countries. All participants provided written informed consent. Regulatory compliance is implied through adherence to ethical standards.

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The study reports ethical approval from a named ethics committee and states that informed consent was obtained from all participants.

Evidence

“The trial protocol (see supplement 1) was approved by the UK National Research Ethics Service (ID 209688) and by responsible ethics committees in all participating countries.”

Methods ¶2Find in source

“All participants provided written informed consent.”

Methods ¶2Find in source

“The trial protocol (see supplement 1) was approved by the UK National Research Ethics Service (ID 209688) and by responsible ethics committees in all participating countries.”

Methods ¶2Find in source

PASSReviewer 2· 95% conf

Ethical approval and informed consent are clearly documented.

Evidence

“The trial protocol (see supplement 1) was approved by the UK National Research Ethics Service (IRAS ID 209688) and by responsible ethics committees in all participating countries.”

EthicsFind in source

“All participants provided written informed consent.”

MethodsFind in source

The cardiac output monitoring system (Edwards Lifesciences EV1000/HemoSphere with ClearSight or FloTrac) is identified with manufacturer. Inotropes (dobutamine, dopexamine) are named with doses. Statistical software is identified (Stata, version 17). Bench criteria are not applicable as this is a clinical trial without wet-lab assays.

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· 80% conf

Key resources like cardiac output monitoring systems and investigational drugs are identified with vendor information.

Evidence

“Cardiac output and associated haemodynamic variables were monitored using an Edwards Lifesciences (Irvine, CA) system comprising an EV1000 or HemoSphere monitor with either ClearSight (non-invasive) cuff or FloTrac (invasive arterial pressure) sensor depending on clinician choice.”

Methods ¶3Find in source

“Intervention group participants also received a fixed, low dose, equipotent infusion of either dobutamine (2.5 µg/kg/min) or dopexamine (0.5 µg/kg/min), chosen based on clinician preference and local availability, and started after the first fluid bolus.”

Methods ¶5Find in source

absence[Methods, Statistical analysis]

Statistical software used is not explicitly identified by name and version.

PASSReviewer 2· 90% conf

The investigational product (cardiac output monitor and inotropes) is adequately identified, and statistical software is named.

Evidence

MethodsFind in source

paraphrase[Methods, Statistical analysis]

“All analyses were performed using Stata version 17 (StataCorp, College Station, TX).”

The paper names mixed-effects logistic regression models, specifies covariates, and uses restricted cubic splines for continuous variables. It reports adjusted odds ratios with 95% confidence intervals and exact p-values. Data presentation includes per-group Ns and percentages. The statistical analysis plan was publicly available and finalized before unblinding.

Sub-criteria

tests namedADEQUATE

exact p valuesADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedNOT REPORTED

assumptions verifiedADEQUATE

mathematical plausibilityN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Statistical methods are well-described, including specific tests, adjustment for covariates, and reporting of effect sizes with confidence intervals.

Evidence

“The primary outcome was analysed using a mixed effects logistic regression model with a random intercept for country and fixed effects: surgical procedure category, age, sex, ASA class, and baseline haemoglobin and creatinine levels.”

Statistical analysis ¶2Find in source

“adjusted odds ratio 1.03 (95% confidence interval 0.84 to 1.25); P=0.81”

AbstractFind in source

“Postoperative infection <30 days of randomisation (primary outcome) | 1247 (99.7) | 1247 (100) | 289 (23.2) | 283 (22.7) | 1.03 (0.84 to 1.25) | 0.81 | 0.4 (−3.4 to 4.2) | 1.03 (0.85 to 1.25) | 0.75 | 0.5 (−3.3 to 4.3)”

Table 3Find in source

PASSReviewer 2· 90% conf

Statistical methods are appropriate and well-reported, with effect sizes and confidence intervals provided.

Evidence

Statistical analysisFind in source

“adjusted odds ratio 1.03, 95% confidence interval (CI) 0.84 to 1.25; P=0.81”

Results ¶2Find in source

The data availability statement indicates that deidentified data will be shared with authenticated researchers who guarantee confidentiality, but it does not name a specific repository, data access committee, or detailed request procedure. No custom code is mentioned as being developed or shared.

Sub-criteria

code sharingN/A

accession numbersN/A

repository depositN/A

data availability statementINADEQUATE

Per reviewer (2) — the votes behind the verdict

WARNReviewer 1· 80% conf

A data availability statement is present, but it describes a managed access process without specifying a platform or detailed conditions.

Evidence

“Deidentified data will be shared with other authenticated researchers for further research and research publications on this topic, but only if they guarantee to preserve the confidentiality of the information requested. Requests for data sharing will be considered by the data sharing committee o”

Data availabilityFind in source

absence[Data availability statement]

No public repository or accession numbers are provided for raw data.

absence[Paper text]

No custom code is mentioned or shared.

WARNReviewer 2· 80% conf

A data availability statement exists but is vague, lacking a concrete access mechanism or timeframe.

Evidence

Data availabilityFind in source

Trial registration number is provided (ISRCTN39653756). Methods are comprehensive. Limitations are explicitly discussed. Conclusions are proportional to the results. Funding sources and competing interests are declared.

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

The study demonstrates high reporting completeness, including trial registration, detailed methods, discussion of limitations, and funding/COI statements.

Evidence

“Trial registration ISRCTN Registry ISRCTN39653756.”

AbstractFind in source

“Supplement 3 provides details of the trial’s standard operating procedures for the care of participants in the intervention and usual care groups.”

Methods ¶1Find in source

“Our trial also has some limitations. It was not possible to conceal group allocation during administration of this complex intervention.”

LimitationsFind in source

“Funding: The trial was funded by Edwards Lifesciences (Irvine, CA, USA) and the UK National Institute for Health and Care Research (NIHR).”

FundingFind in source

PASSReviewer 2· 95% conf

The trial is registered, methods are detailed, limitations are discussed, and funding/COI are disclosed.

Evidence

“Trial registration ISRCTN Registry ISRCTN39653756.”

AbstractFind in source

“Our trial also has some limitations. It was not possible to conceal group allocation during administration of this complex intervention.”

LimitationsFind in source

Registered (1 ID: ISRCTN). No reporting guideline cited.

Broken references and links

None found

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.

Checked — nothing surfaced.

Checked 42 references by DOI: 42 verified.

1 data/code link checked; 1 live.

Copyediting

8 minor

Wording, consistency and formatting errors that need correcting before submission.

No major wording or formatting errors. 8 minor suggestions below.

8 copyedit issues flagged: mostly punctuation, consistency, clarity.

Kaimen Rigor Action ItemsFinal pass before journal submission

The published work is robust and generally well-reported. An informed reader should weigh the vague data availability statement and the minor reporting inconsistencies (e.g., missing figure/table references) as areas that could warrant clarification or a correction. The statistical verification found some inconsistencies, but without specific details, these do not undermine the overall conclusions.

1.
HIGHdata code
In the Data availability statement, specify a concrete access route: name the data sharing committee, provide a contact email or a platform (e.g., YODA, Vivli), and state the conditions and expected timeframe for data requests.
The current statement is vague and does not provide a clear mechanism for researchers to request data, which is a common requirement for reproducibility.
2.
HIGHdata code
Add a statement about code sharing: if any custom analysis code was used, deposit it in a public repository (e.g., Zenodo) with a DOI and link it in the manuscript.
Sharing analysis code enhances transparency and allows others to reproduce the statistical analyses.
3.
MEDIUMreporting
Add a CONSORT flow diagram as a figure (if not already included) to improve reporting transparency.
A CONSORT flow diagram is a standard requirement for reporting randomised trials and helps readers track participant flow.
4.
MEDIUMreporting
In the Methods, explicitly state that the trial was reported according to CONSORT guidelines and provide the checklist as supplementary material.
Explicitly stating adherence to CONSORT and providing the checklist demonstrates compliance with reporting standards.
5.
MEDIUMcopyedit
Fix missing references to tables and figures in the Results section: add 'Figure 1' after 'after surgery ()', add 'Table 3 and Figure 2' after 'acute cardiac event within 24 hours', add 'Table 3' after 'did not differ between the two groups', and add 'Table 3' after 'minimally adjusted analysis'.
Missing cross-references reduce clarity and make it harder for readers to locate the supporting data.
6.
MEDIUMcopyedit
Standardize the abbreviation for standard deviation: use 'SD' consistently instead of 'standard deviation' in the Abstract.
Consistent terminology improves readability and professionalism.
7.
MEDIUMcopyedit
Align the percentage of women in the Abstract (57%) with the Results (57.3%) for consistency.
Inconsistent numbers between the abstract and results can confuse readers and may be flagged during review.
8.
LOWcopyedit
Capitalize 'Randomised Clinical Trial' in the Abstract for consistency with trial naming conventions.
Consistent capitalization of trial names is a minor but professional detail.
9.
LOWcopyedit
Rephrase the sentence in Methods, Statistical analysis for clarity: 'ASA class and procedure were included as categorical variables using the same categories as in the minimisation algorithm.'
The current phrasing is slightly awkward; the suggested rephrasing is clearer.

Full text (67,904 chars)Analyzed: Aug 16, 2026

Start the discussion on JRNLClub

Community discussion on jrnlclub.com

Read alongside

Cardiac output-guided haemodynamic therapy for patients undergoing major gastrointestinal surgery: OPTIMISE II randomised clinical trial.

OPTIMISE II Trial Group

Read full text (PMC)

DOI

10.1136/bmj-2024-080439

Share this Kaimen Rigor review

Post on X Share on LinkedIn Share via Email

Embed this Rigor badge

<a href="https://alpha1science.com/verify/7dd2308a-731f-46a7-a31a-54a0b6d151e7" target="_blank" rel="noopener">
  <img src="https://alpha1science.com/verify/7dd2308a-731f-46a7-a31a-54a0b6d151e7/badge" alt="Kaimen Rigor review — 4.5★ (Strong), 0 critical, 2 high issues for “Cardiac output-guided haemodynamic therapy for patients undergoing major gastrointestinal surgery: OPTIMISE II randomised clinical trial.”" width="440" height="104" style="max-width:100%;height:auto" />
</a>

Every embed links back to this Kaimen Rigor review.

Record fingerprint

61d57027699bdc4cdb9492fa99b15d2d98c5258d1f43e6c72bb795ace248cf2a

Verify via API

Issued Aug 16, 2026Engine 7.39.0

Alpha1 assesses methodological rigor, not the importance of the findings. See how we calibrate →

Kaimen Rigor review

Kaimen Rigor reviewed

4.5 / 5

Strong — minor issues to address

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

StatisticsPrinted percentage does not match its own count (capped) ×3−0.25★
ReportingData & code availability partially met−0.25★

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

Not verified in this report

The numeric-impossibility checks (GRIM/GRIMMER/DEBIT/SPRITE) did not run: 10 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.

Biggest issues

01Printed percentage does not match its own count
mediumArithmeticrecomputedFull detail
92.6% does not match the reported count 1156/1251
“1156 (92.6)”
Table 2
02Printed percentage does not match its own count
mediumArithmeticrecomputedFull detail
80.5% does not match the reported count 1005/1251
“1005 (80.5)”
Table 2
03Printed percentage does not match its own count
mediumArithmeticrecomputedFull detail
73.1% does not match the reported count 908/1247
“908 (73.1)”
Table 2

Findings by category

101ArithmeticNumerical inconsistencies 02OverreachNone found 03AuthenticityNone found 104DisclosureReporting gaps 05AvailabilityNone found 06Copyedit8 minor suggestions

Numerical inconsistencies

1 finding · worst medium

Printed percentage does not match its own countRecomputed

Recomputed 6 tests: 6 consistent, 0 inconsistent; 1 recomputed directly from the reported test statistics, 5 via agent-written checks. 3 printed percentages that do not match their own count.

Overstated conclusions

None found

Checked — nothing surfaced.

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

Data authenticity concerns

None found

Checked — nothing surfaced.

Reporting gaps

1 finding · worst medium

Data/code availability incompleteAssessed

Eight Dimensions7 pass · 1 warn

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The study clearly establishes its scientific premise by citing prior work, outlining the rationale for the intervention, and discussing limitations of previous research.

Evidence

“Cardiac output-guided therapy has proved controversial at times, and excessive early pulmonary artery catheter use generated safety concerns.”

Introduction ¶3Find in source

Introduction ¶2Find in source

Introduction ¶4Find in source

PASSReviewer 2· 90% conf

The paper establishes a clear scientific premise, citing prior work and providing a logical rationale for the trial.

Evidence

Introduction ¶4Find in source

“We hypothesised that this intervention would reduce postoperative infections compared with usual clinical care.”

Introduction ¶4Find in source

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· 90% conf

The study design is robust, detailing randomisation, blinding, power analysis, and inclusion/exclusion criteria appropriate for a clinical trial.

Evidence

Methods ¶1Find in source

Methods ¶2Find in source

Statistical analysis ¶1Find in source

PASSReviewer 2· 95% conf

The trial design is rigorous: randomisation method, blinding, power analysis, inclusion/exclusion criteria, and analysis population are all adequately described.

Evidence

MethodsFind in source

“Research staff collecting and assessing clinical outcomes were not involved in the participants’ care and were unaware of study group allocation.”

MethodsFind in source

Statistical analysisFind in source

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

Demographic and clinical characteristics of participants are comprehensively reported, including age, sex, ASA status, and comorbidities.

Evidence

“In 2498 patients (mean age 74 (standard deviation 6) years, 57% women)”

AbstractFind in source

paraphrase[Table 1]

“Table 1 Baseline characteristics of participants. Values are number (percentage) unless stated otherwise”

Table 1Find in source

PASSReviewer 2· 90% conf

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

Evidence

“Mean age was 74 (standard deviation 6) years and 1432/2498 (57.3%) participants were women.”

Results ¶1Find in source

“Table 1 Baseline characteristics of participants. Values are number (percentage) unless stated otherwise”

Table 1Find in source

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The study reports ethical approval from a named ethics committee and states that informed consent was obtained from all participants.

Evidence

“The trial protocol (see supplement 1) was approved by the UK National Research Ethics Service (ID 209688) and by responsible ethics committees in all participating countries.”

Methods ¶2Find in source

“All participants provided written informed consent.”

Methods ¶2Find in source

“The trial protocol (see supplement 1) was approved by the UK National Research Ethics Service (ID 209688) and by responsible ethics committees in all participating countries.”

Methods ¶2Find in source

PASSReviewer 2· 95% conf

Ethical approval and informed consent are clearly documented.

Evidence

“The trial protocol (see supplement 1) was approved by the UK National Research Ethics Service (IRAS ID 209688) and by responsible ethics committees in all participating countries.”

EthicsFind in source

“All participants provided written informed consent.”

MethodsFind in source

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· 80% conf

Key resources like cardiac output monitoring systems and investigational drugs are identified with vendor information.

Evidence

Methods ¶3Find in source

Methods ¶5Find in source

absence[Methods, Statistical analysis]

Statistical software used is not explicitly identified by name and version.

PASSReviewer 2· 90% conf

The investigational product (cardiac output monitor and inotropes) is adequately identified, and statistical software is named.

Evidence

MethodsFind in source

paraphrase[Methods, Statistical analysis]

“All analyses were performed using Stata version 17 (StataCorp, College Station, TX).”

Sub-criteria

tests namedADEQUATE

exact p valuesADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedNOT REPORTED

assumptions verifiedADEQUATE

mathematical plausibilityN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Statistical methods are well-described, including specific tests, adjustment for covariates, and reporting of effect sizes with confidence intervals.

Evidence

Statistical analysis ¶2Find in source

“adjusted odds ratio 1.03 (95% confidence interval 0.84 to 1.25); P=0.81”

AbstractFind in source

Table 3Find in source

PASSReviewer 2· 90% conf

Statistical methods are appropriate and well-reported, with effect sizes and confidence intervals provided.

Evidence

Statistical analysisFind in source

“adjusted odds ratio 1.03, 95% confidence interval (CI) 0.84 to 1.25; P=0.81”

Results ¶2Find in source

Sub-criteria

code sharingN/A

accession numbersN/A

repository depositN/A

data availability statementINADEQUATE

Per reviewer (2) — the votes behind the verdict

WARNReviewer 1· 80% conf

A data availability statement is present, but it describes a managed access process without specifying a platform or detailed conditions.

Evidence

Data availabilityFind in source

absence[Data availability statement]

No public repository or accession numbers are provided for raw data.

absence[Paper text]

No custom code is mentioned or shared.

WARNReviewer 2· 80% conf

A data availability statement exists but is vague, lacking a concrete access mechanism or timeframe.

Evidence

Data availabilityFind in source

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

The study demonstrates high reporting completeness, including trial registration, detailed methods, discussion of limitations, and funding/COI statements.

Evidence

“Trial registration ISRCTN Registry ISRCTN39653756.”

AbstractFind in source

“Supplement 3 provides details of the trial’s standard operating procedures for the care of participants in the intervention and usual care groups.”

Methods ¶1Find in source

“Our trial also has some limitations. It was not possible to conceal group allocation during administration of this complex intervention.”

LimitationsFind in source

“Funding: The trial was funded by Edwards Lifesciences (Irvine, CA, USA) and the UK National Institute for Health and Care Research (NIHR).”

FundingFind in source

PASSReviewer 2· 95% conf

The trial is registered, methods are detailed, limitations are discussed, and funding/COI are disclosed.

Evidence

“Trial registration ISRCTN Registry ISRCTN39653756.”

AbstractFind in source

“Our trial also has some limitations. It was not possible to conceal group allocation during administration of this complex intervention.”

LimitationsFind in source

Registered (1 ID: ISRCTN). No reporting guideline cited.

Broken references and links

None found

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.

Checked — nothing surfaced.

Checked 42 references by DOI: 42 verified.

1 data/code link checked; 1 live.

Copyediting

8 minor

Wording, consistency and formatting errors that need correcting before submission.

No major wording or formatting errors. 8 minor suggestions below.

8 copyedit issues flagged: mostly punctuation, consistency, clarity.

Kaimen Rigor Action ItemsFinal pass before journal submission

1.
HIGHdata code
In the Data availability statement, specify a concrete access route: name the data sharing committee, provide a contact email or a platform (e.g., YODA, Vivli), and state the conditions and expected timeframe for data requests.
The current statement is vague and does not provide a clear mechanism for researchers to request data, which is a common requirement for reproducibility.
2.
HIGHdata code
Add a statement about code sharing: if any custom analysis code was used, deposit it in a public repository (e.g., Zenodo) with a DOI and link it in the manuscript.
Sharing analysis code enhances transparency and allows others to reproduce the statistical analyses.
3.
MEDIUMreporting
Add a CONSORT flow diagram as a figure (if not already included) to improve reporting transparency.
A CONSORT flow diagram is a standard requirement for reporting randomised trials and helps readers track participant flow.
4.
MEDIUMreporting
In the Methods, explicitly state that the trial was reported according to CONSORT guidelines and provide the checklist as supplementary material.
Explicitly stating adherence to CONSORT and providing the checklist demonstrates compliance with reporting standards.
5.
MEDIUMcopyedit
Fix missing references to tables and figures in the Results section: add 'Figure 1' after 'after surgery ()', add 'Table 3 and Figure 2' after 'acute cardiac event within 24 hours', add 'Table 3' after 'did not differ between the two groups', and add 'Table 3' after 'minimally adjusted analysis'.
Missing cross-references reduce clarity and make it harder for readers to locate the supporting data.
6.
MEDIUMcopyedit
Standardize the abbreviation for standard deviation: use 'SD' consistently instead of 'standard deviation' in the Abstract.
Consistent terminology improves readability and professionalism.
7.
MEDIUMcopyedit
Align the percentage of women in the Abstract (57%) with the Results (57.3%) for consistency.
Inconsistent numbers between the abstract and results can confuse readers and may be flagged during review.
8.
LOWcopyedit
Capitalize 'Randomised Clinical Trial' in the Abstract for consistency with trial naming conventions.
Consistent capitalization of trial names is a minor but professional detail.
9.
LOWcopyedit
Rephrase the sentence in Methods, Statistical analysis for clarity: 'ASA class and procedure were included as categorical variables using the same categories as in the minimisation algorithm.'
The current phrasing is slightly awkward; the suggested rephrasing is clearer.

Full text (67,904 chars)Analyzed: Aug 16, 2026