Care guided by tissue oxygenation and haemodynamic monitoring in off-pump coronary artery bypass grafting (Bottomline-CS): assessor blind, single centre, randomised controlled trial.
Han J, Zhai W, Wu Z, Zhang Z, Wang T, Ren M, Liu Z, Sessler DI, Guo Z, Meng L, Bottomline-CS investigation group
- DOI
- 10.1136/bmj-2024-082104
- Record issued
- 2026-08-15
- Engine
- 7.39.0
- Exported
- 2026-09-20
Prepared by Alpha1. This document is confidential: it is intended for the recipient it was shared with and must not be redistributed. The live record at alpha1science.com/verify/6516d52e-eaac-4e3b-9dee-9d80f653b843 is authoritative.
How this rating was calculated
- IntegrityIntegrity concern ×2−1★
- ClaimsEfficacy rests on an unvalidated surrogate endpoint−0.5★
- ClaimsTreatment effect not shown to be clinically meaningful−0.5★
- CitationsUnresolved reference−0.25★
- The numeric-impossibility checks (GRIM/GRIMMER/DEBIT/SPRITE) did not run: 34 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.
- 01Efficacy rests on an unvalidated surrogate endpoint
The primary efficacy claim is based on a composite of hard clinical outcomes (postoperative complications), but the intervention's mechanism is guided by tissue oxygen saturation (a surrogate biomarker). The paper does not provide validated evidence linking tissue oxygen saturation to the clinical outcomes, nor does it demonstrate target engagement at the tested dose beyond achieving the physiological target. The surrogate is used as a guide, not as the primary endpoint, but the efficacy claim relies on the assumption that maintaining tissue oxygenation improves outcomes, which is not validated.
“Guided care aimed to maintain tissue oxygenation within 10% above or below preoperative baseline values... The primary outcome was the incidence of a composite of 30 day postoperative complications... The primary composite outcome occurred in 457/967 (47.3%)…”
- 02Treatment effect not shown to be clinically meaningful
The primary effect size is a risk ratio of 0.99 with a confidence interval crossing 1, indicating no significant benefit. The paper reports no clinically meaningful improvement in the primary outcome. The only notable difference was in pneumonia (9.1% vs 12.4%), but this was not statistically significant after adjustment for multiple comparisons. The effect size is not anchored to a minimal clinically important difference, and the primary outcome shows no benefit.
“The primary composite outcome occurred in 457/967 (47.3%) patients in the guided care group and 466/974 (47.8%) patients in the usual care group (unadjusted risk ratio 0.99 (95% confidence interval 0.90 to 1.08), P=0.83).”
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 transparently reported randomised controlled trial. The design is rigorous (randomisation, blinding of assessors, pre-specified sample size), ethical approvals and data/code availability are clearly documented, and the statistical analysis is appropriately described with exact p-values and effect sizes. Minor copyedit issues and a single unresolved reference are the only notable weaknesses.
Both reviewers classified the study as interventional (RCT), and I adopt that classification. The evaluation covered all eight rigor dimensions; non-applicable sub-criteria (e.g., species/strain, housing, IACUC, cell lines) were excluded. The statistics component verified only a subset of tests (those with test statistics/df or effect estimates with CIs); threshold-only p-values and resampling-based p-values were not machine-verified. The citation check flagged one reference not found in any registry.
Numerical inconsistencies
1 finding · worst lowValues 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
Recomputed 5 tests: 5 consistent, 0 inconsistent; 2 recomputed directly from the reported test statistics, 3 via agent-written checks.
- CONSISTENTreported p = .830 · recomputed p = .829Recomputed risk ratio 0.99 (95% CI 0.90–1.08), reported p=0.83
“risk ratio 0.99 (95% confidence interval 0.90 to 1.08), P=0.83”
Taken as given: 0.90–1.08 is a two-sided 95% confidence interval for the risk ratio of 0.99, not a range, an IQR, or a different interval level; the risk ratio is a RATIO measure, so the interval is symmetric on the log scale; p=0.83 is the p for THIS estimate, not for another comparison in the same sentenceMethod: back the two-tailed p out of the log-scale CI width and compare it against the printed pHow we recomputed it: pCI(0.99, 0.9, 1.08, 1) - CONSISTENTreported p = .020 · recomputed p = .016Recomputed risk ratio 0.72 (95% CI 0.55–0.94), reported p=0.02
“risk ratio 0.72 (95% CI 0.55 to 0.94), P=0.02”
Taken as given: 0.55–0.94 is a two-sided 95% confidence interval for the risk ratio of 0.72, not a range, an IQR, or a different interval level; the risk ratio is a RATIO measure, so the interval is symmetric on the log scale; p=0.02 is the p for THIS estimate, not for another comparison in the same sentenceMethod: back the two-tailed p out of the log-scale CI width and compare it against the printed pHow we recomputed it: pCI(0.72, 0.55, 0.94, 1) - CONSISTENTreported p = .830 · recomputed p = .829Reviewers 1, 2Primary outcome risk ratio p-value from reported RR and 95% CI
“resulting in an unadjusted risk ratio of 0.99 (95% CI 0.90 to 1.08), P=0.83).”
Taken as given: The risk ratio is 0.99 with 95% CI 0.90 to 1.08.; The p-value is two-sided.; The CI is a 95% confidence interval for the risk ratio.Method: Recomputed two-sided p-value from the reported RR and 95% CI using the normal approximation for the log risk ratio.How we recomputed it: pCI(0.99, 0.90, 1.08, 1) - CONSISTENTreported p = .020 · recomputed p = .020Reviewers 1, 2Pneumonia risk ratio p-value from reported RR and 95% CI
“Pneumonia occurred in 88 (9.1%) of 967 patients in the guided care group and 121 (12.4%) of 974 patients in the usual care group, with an unadjusted risk ratio of 0.73 ((95% CI 0.56 to 0.95), P=0.02 before adjustment for multiple comparisons”
Taken as given: The risk ratio is 0.73 with 95% CI 0.56 to 0.95.; The p-value is two-sided.; The CI is a 95% confidence interval for the risk ratio.Method: Recomputed two-sided p-value from the reported RR and 95% CI using the normal approximation for the log risk ratio.How we recomputed it: pCI(0.73, 0.56, 0.95, 1) - CONSISTENTreported p = .080 · recomputed p = .066Reviewers 1, 2Stroke risk ratio p-value from reported RR and 95% CI
“Stroke occurred in six (0.6%) of 967 patients versus 15 (1.5%) of 974 patients, with an unadjusted risk ratio of 0.40 ((0.14 to 0.99), P=0.08 before adjustment”
Taken as given: The risk ratio is 0.40 with 95% CI 0.14 to 0.99.; The p-value is two-sided.; The CI is a 95% confidence interval for the risk ratio.Method: Recomputed two-sided p-value from the reported RR and 95% CI using the normal approximation for the log risk ratio.How we recomputed it: pCI(0.40, 0.14, 0.99, 1)
- lowinternal contradictionThe abstract reports 'data from 967 guided care and 974 usual care patients were analysed' but the results section states '13 patients in the guided care group and six in the usual care group had their surgery cancelled or were lost to follow-up', which would imply 980-13=967 and 980-6=974, consistent. No contradiction.
“Of 1960 patients randomly assigned, data from 967 guided care and 974 usual care patients were analysed.”
AbstractFind in source
Overstated conclusions
3 findings · worst highConclusions 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.
- Efficacy rests on an unvalidated surrogate endpointAssessed
- Treatment effect not shown to be clinically meaningfulAssessed
- Conclusions only partially backed by the presented evidenceAssessed
7 major claims checked against the paper's own evidence: 1 only partially supported (evidence backs part of the claim; gaps or caveats remain); the rest adequately supported.
- partialReviewer 1The pneumonia reduction may be a true benefit but is likely spurious.The paper acknowledges uncertainty and notes the spurious explanation is more likely, but the evidence is insufficient to confirm either.Evidence: Pneumonia RR 0.73 (95% CI 0.56 to 0.95), P=0.02 before adjustment, P=0.60 after adjustment.
“Whether this reduction reflects a true benefit that did not reach statistical significance because of insufficient power or is a spurious finding from multiple comparisons remains uncertain. The spurious finding explanation is more likely.”
DiscussionFind in source - supportedReviewers 1, 2Guided care effectively maintained tissue oxygenation near baseline levels compared with usual care.The paper provides direct evidence of significantly smaller AUC and higher proportion of patients within ±10% baseline in the guided care group.Evidence: Table 3 shows significantly smaller AUC for all three sites and higher percentages within ±10% baseline (95.1% vs 60.0% for left forehead, etc.).
“During anaesthesia, the area under the curve for tissue oxygen saturation measurements outside the plus and minus 10% baseline range was significantly smaller with guided care than only usual care: left forehead 32.4 versus 57.6 (%×min, P<0.001), right forehead 37.9 versus 62.6 (P<0.001), and forearm 14.8 versus 44.7 (P<0.001).”
AbstractFind in source - supportedReviewer 1Guided care did not reduce the incidence of major postoperative complications.The primary composite outcome did not differ significantly between groups, with a narrow confidence interval.Evidence: Primary outcome occurred in 457/967 (47.3%) vs 466/974 (47.8%), RR 0.99 (95% CI 0.90 to 1.08), P=0.83.
“The primary composite outcome occurred in 457/967 (47.3%) patients in the guided care group and 466/974 (47.8%) patients in the usual care group (unadjusted risk ratio 0.99 (95% confidence interval 0.90 to 1.08), P=0.83).”
AbstractFind in source - supportedReviewer 1No secondary outcomes differed significantly between groups.All secondary outcomes were not significant after adjustment for multiple comparisons.Evidence: The paper states 'None of the secondary analyses showed statistically significant between-group differences after adjustments for multiple comparisons using the Holm-Bonferroni method.'
“None of the secondary analyses showed statistically significant between-group differences after adjustments for multiple comparisons using the Holm-Bonferroni method.”
ResultsFind in source - supportedReviewers 1, 2The findings do not support the routine use of near-infrared spectroscopy and haemodynamic monitoring to maintain tissue oxygenation during off-pump CABG.The neutral primary result supports this conclusion.Evidence: Primary outcome neutral; conclusion is proportional.
“These findings do not support the routine use of near-infrared spectroscopy and haemodynamic monitoring to maintain tissue oxygenation during off-pump coronary artery bypass grafting.”
ConclusionFind in source - supportedReviewer 2No clear evidence was noted that this approach reduced the incidence of major postoperative complications.The primary composite outcome did not differ significantly between groups, with a risk ratio of 0.99 and a narrow confidence interval.Evidence: Primary outcome occurred in 457/967 (47.3%) vs 466/974 (47.8%), RR 0.99 (95% CI 0.90 to 1.08), P=0.83.
“However, no clear evidence was noted that this approach reduced the incidence of major postoperative complications.”
AbstractFind in source - supportedReviewer 2The narrow confidence interval for the primary composite relative risk (width of 0.18) underscores the robustness of these neutral findings, ruling out insufficient power as an explanation.The confidence interval width is indeed narrow, and the observed event rate was higher than assumed, increasing power.Evidence: RR 0.99 (95% CI 0.90 to 1.08), width 0.18.
“The narrow confidence interval for the primary composite relative risk (width of 0.18) underscores the robustness of these neutral findings, ruling out insufficient power as an explanation.”
ConclusionFind in source
Premise concern: surrogate not validated for clinical benefit; effect size not shown to be clinically meaningful.
- INADEQUATESurrogate endpointThe primary efficacy claim is based on a composite of hard clinical outcomes (postoperative complications), but the intervention's mechanism is guided by tissue oxygen saturation (a surrogate biomarker). The paper does not provide validated evidence linking tissue oxygen saturation to the clinical outcomes, nor does it demonstrate target engagement at the tested dose beyond achieving the physiological target. The surrogate is used as a guide, not as the primary endpoint, but the efficacy claim relies on the assumption that maintaining tissue oxygenation improves outcomes, which is not validated.
“Guided care aimed to maintain tissue oxygenation within 10% above or below preoperative baseline values... The primary outcome was the incidence of a composite of 30 day postoperative complications... The primary composite outcome occurred in 457/967 (47.3%) patients in the guided care group and 466/974 (47.8%) patients in the usual care group (unadjusted risk ratio 0.99 (95% confidence interval 0.90 to 1.08), P=0.83).”
- INADEQUATEEffect sizeThe primary effect size is a risk ratio of 0.99 with a confidence interval crossing 1, indicating no significant benefit. The paper reports no clinically meaningful improvement in the primary outcome. The only notable difference was in pneumonia (9.1% vs 12.4%), but this was not statistically significant after adjustment for multiple comparisons. The effect size is not anchored to a minimal clinically important difference, and the primary outcome shows no benefit.
“The primary composite outcome occurred in 457/967 (47.3%) patients in the guided care group and 466/974 (47.8%) patients in the usual care group (unadjusted risk ratio 0.99 (95% confidence interval 0.90 to 1.08), P=0.83).”
Data authenticity concerns
1 finding · worst lowAn 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.
- Other integrity concernAssessed
2 integrity concerns flagged (0 high).
- lowotherThe paper reports a higher than expected event rate (47% vs 30% assumed), which is acknowledged and used to argue for adequate power; this is not a concern but a notable deviation from the sample size assumption.
“We initially estimated that 30% of patients randomly assigned to usual care would have complications included in the composite outcome. In reality, 47% of patients had one or more such complications.”
DiscussionFind in source
Reporting gaps
None foundRequired detail the manuscript never states — study design, biological variables, ethics approval and consent, key resources, statistical reporting, data and code availability, and overall transparency.
Checked — nothing surfaced.
The introduction cites prior cohort studies linking tissue desaturation to worse outcomes and notes that previous randomised trials were small, underpowered, and focused solely on cerebral oximetry. It explicitly states the limitations of prior work (e.g., 'These trials were often small (the largest enrolling 249 patients), inadequately powered, and focused solely on cerebral tissue oxygen saturation') and explains how the current study addresses these gaps by using multisite monitoring and continuous haemodynamic data. The hypothesis follows logically from the cited evidence.
“These trials were often small (the largest enrolling 249 patients), inadequately powered, and focused solely on cerebral tissue oxygen saturation—potentially overlooking perfusion deficits in non-cerebral tissues.”
“However, randomised trials have yielded inconsistent results. These trials were often small (the largest enrolling 249 patients), inadequately powered, and focused solely on cerebral tissue oxygen saturation—potentially overlooking perfusion deficits in non-cerebral tissues.”
Randomisation used computer-generated allocations in blocks of four, accessed via a secure website, with the generator not involved in management or assessment. Outcome assessors were masked, and patients were not informed of allocation. A sample size calculation was performed assuming a 30% vs 24% event rate, with 80% power and a type I error of 0.05, targeting 980 per group to account for 5% dropout. Inclusion/exclusion criteria were pre-specified. The trial is a human RCT, so replicate_distinction, controls, and independent_replication are not applicable; outlier_handling is addressed through the modified intention-to-treat analysis and sensitivity analyses for missing data.
“Patients were randomised 1:1 to guided or usual perioperative care using computer generated allocations in blocks of four, accessed via a secure website on the morning of surgery.”
“However, outcome assessors were independent, uninvolved in perioperative care, and masked to group assignments.”
“The required sample size was 927 patients per group to achieve 80% power to detect a 6% absolute reduction in the primary outcome incidence (from 30% to 24%) at a type I error level of 0.05.”
“Patients were randomised 1:1 to guided or usual perioperative care using computer generated allocations in blocks of four, accessed via a secure website on the morning of surgery.”
“However, outcome assessors were independent, uninvolved in perioperative care, and masked to group assignments.”
“The required sample size was 927 patients per group to achieve 80% power to detect a 6% absolute reduction in the primary outcome incidence (from 30% to 24%) at a type I error level of 0.05.”
The paper reports age, sex, height, weight, BMI, smoking, diabetes, hypertension, and other comorbidities in Table 1. Both sexes are included (70.9% male in guided care, 69.3% in usual care), so a justification for single-sex is not required. Age and health status are reported. Species/strain and housing conditions are not applicable for a human trial.
“Mean age (SD), year | 69 (5) | 69 (5) | | Male, no. (%) | 686 (70.9) | 675 (69.3)”
“Mean age (SD), year | 69 (5) | 69 (5) | | Male, no. (%) | 686 (70.9) | 675 (69.3)”
The paper states approval by the internal review board of Tianjin Chest Hospital with a protocol number (2021KY-008-001). Written informed consent was obtained from participants at least 24 hours before surgery. The trial was registered at ClinicalTrials.gov. Regulatory compliance is implied through adherence to CONSORT and ICMJE disclosure, though not explicitly naming a framework like the Declaration of Helsinki; however, the named IRB approval and consent are sufficient.
“The study protocol was approved by the internal review board of Tianjin Chest Hospital (2021KY-008-001).”
“Written informed consent was obtained from participants at least 24 h before surgery.”
“The study protocol was approved by the internal review board of Tianjin Chest Hospital (2021KY-008-001).”
“Written informed consent was obtained from participants at least 24 h before surgery.”
The trial uses two investigational devices: the Nonin Medical near-infrared spectroscopy oximeter and the Masimo LiDCO haemodynamic monitoring system, both identified with manufacturer and location. These are scored under reagents_identified as the investigational products. Statistical software R version 4.4.0 is identified. Antibodies, cell lines, mycoplasma, and organisms are not applicable.
“Tissue oxygen saturation was assessed using near-infrared spectroscopy cerebral and tissue oximetry (Nonin Medical, Plymouth, MN, USA).”
“Statistical analyses were performed using R (version 4.4.0, R Foundation for Statistical Computing, Vienna, Austria)”
“Tissue oxygen saturation was assessed using near-infrared spectroscopy cerebral and tissue oximetry (Nonin Medical, Plymouth, MN, USA).”
“Statistical analyses were performed using R (version 4.4.0, R Foundation for Statistical Computing, Vienna, Austria)”
The paper names statistical tests (t-tests, Wilcoxon rank-sum, chi-squared, Fisher's exact, log-binomial regression) and provides exact p-values (e.g., P=0.83 for primary outcome). Effect sizes are reported as risk ratios with 95% CIs. Software (R 4.4.0) is identified. Data presentation includes CONSORT flow diagram, Kaplan-Meier-like figures, and per-group n. Assumptions are handled by design (e.g., non-parametric tests for non-normal data). Mathematical plausibility is not applicable for large-N continuous outcomes; however, we verified some proportions and found no inconsistencies.
“Group comparisons for normally distributed data were conducted using t-tests, while Wilcoxon rank-sum tests were used for non-parametric data.”
“Primary composite complications occurred in 457 (47.3%) of 967 patients in the guided care group and 466 (47.8%) of 974 patients in the usual care group, resulting in an unadjusted risk ratio of 0.99 (95% CI 0.90 to 1.08), P=0.83).”
“Group comparisons for normally distributed data were conducted using t-tests, while Wilcoxon rank-sum tests were used for non-parametric data.”
“unadjusted risk ratio 0.99 (95% confidence interval 0.90 to 1.08), P=0.83”
The data availability statement provides a Dryad DOI (10.5061/dryad.z34tmpgqz) for the data and states that code is in supplemental files. This is a concrete access route, meeting the adequate threshold. Repository deposit and accession numbers are satisfied by the Dryad DOI. Code sharing is via supplemental files, which is acceptable though not a version-controlled public repo; however, the statement is concrete.
“The data underlying the findings in this paper are openly and publicly available and can be found here: (DOI: 10.5061/dryad.z34tmpgqz).”
“The code used to analyse the data in the paper can be found in the supplemental files.”
“The data underlying the findings in this paper are openly and publicly available and can be found here: (DOI: 10.5061/dryad.z34tmpgqz).”
“The code used to analyse the data in the paper can be found in the supplemental files.”
The trial is registered at ClinicalTrials.gov (NCT04896736). The paper adheres to CONSORT guidelines. All pre-specified outcomes are reported, including negative results. Limitations are thoroughly discussed. Conclusions are proportional to the evidence. Funding sources and competing interests are declared.
“Trial registration ClinicalTrials.gov NCT04896736”
“This report adheres to the Consolidated Standards of Reporting Trials (CONSORT) guidelines.”
“A limitation of our trial is the open label design, necessitated by the nature of the intervention, which may have introduced performance or detection bias.”
“Trial registration ClinicalTrials.gov NCT04896736”
“This report adheres to the Consolidated Standards of Reporting Trials (CONSORT) guidelines.”
“Funding: This work was supported by the Tianjin Science and Technology Project (No. 20JCZDJC00810; ZG).”
Registered (1 ID: ClinicalTrials.gov). Reporting guideline cited: CONSORT.
Broken references and links
1 finding · worst lowReferences 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
Checked 53 references by DOI: 50 verified — 1 DOI unresolved, 2 no DOI (shown, not verified).
- UNRESOLVED10.11909/j.issn.1671-5411.2017.11.001Near-infrared spectroscopy in adult cardiac surgery: between conflicting results and unexpected usesCited DOI does not resolve to any Crossref record.
- NO DOIA language and environment for statistical computingNo DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
- NO DOICerebral regional tissue Oxygen Saturation to Guide Oxygen Delivery in preterm neonates during immediate transition after birth (COSGOD III): multicentre randomised phase 3 clinical trialNo DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
1 data/code link checked; 1 live.
- datahttps://clinicaltrials.gov/ct2/show/NCT04896736LIVEHTTP 200Resolves, but the content could not be matched to the paper.
Copyediting
7 minorWording, consistency and formatting errors that need correcting before submission.
No major wording or formatting errors. 7 minor suggestions below.
7 copyedit issues flagged: mostly consistency, grammar.
- MINORgrammarAbstract, Results“significantly smaller with guided care than only usual care”→ Remove 'only' for clarity: 'significantly smaller with guided care than with usual care'Awkward phrasing.
- MINORconsistencyResults, Outcomes and estimation“P=0.83).”→ Remove extra closing parenthesis: 'P=0.83).' -> 'P=0.83).'Extra parenthesis after P value.
- MINORgrammarResults, Outcomes and estimation“Infectious complications occurred in 137 (14.2%) of 967 patients versus and 170 (17.5%) of 974 patients”→ Remove 'and' after 'versus'Typographical error.
- MINORconsistencyTable 3 footnote“All patients had left SctO2 baseline measurements. Left SctO2 data were missing in nine patients in the guided care group and 19 in the usual care group.”→ Clarify that 'all patients' refers to those with baseline measurements, and the missing data are for intraoperative measurements.Potential ambiguity.
- MINORconsistencyResults, Outcomes and estimation“resulting in an unadjusted risk ratio of 0.99 (95% CI 0.90 to 1.08), P=0.83).”→ Remove the extra closing parenthesis: '...P=0.83).'Extra parenthesis.
- MINORconsistencyResults, Outcomes and estimation“Stroke occurred in six (0.6%) of 967 patients versus 15 (1.5%) of 974 patients, with an unadjusted risk ratio of 0.40 ((0.14 to 0.99), P=0.08 before adjustment, P>0.99 after adjustment).”→ Remove double parenthesis: '0.40 (0.14 to 0.99)'Double parenthesis.
- MINORgrammarResults, Ancillary analyses“Stroke occurred in three of 901 patients (0.3%) versus 13 (1.3%) of 964 patients (0.25 (0.06 to 0.76), P=0.03 before adjustment, P=0.88 after adjustment).”→ Add 'risk ratio' before the parentheses for clarity.Missing 'risk ratio'.
The published work is robust and well-reported; an informed reader should weigh the minor copyedit issues and the single unresolved reference as low-severity concerns. No erratum or re-analysis is warranted based on the rigor evaluation, though the authors may consider issuing a correction for the typographical errors and verifying the flagged reference.
- 1.HIGHotherVerify or correct the reference 'Near-infrared spectroscopy in adult cardiac surgery: between conflicting results and unexpected uses' (DOI 10.11909/j.issn.1671-5411.2017.11.001), which was not found in any registry; if it cannot be verified, remove or replace it.An unresolved reference may be a fabrication signal and should be resolved before the paper is relied upon.
- 2.MEDIUMcopyeditFix the typographical error in the Abstract Results: change 'significantly smaller with guided care than only usual care' to 'significantly smaller with guided care than with usual care'.Awkward phrasing detracts from clarity.
- 3.MEDIUMcopyeditRemove the extra closing parenthesis after 'P=0.83' in the Results section (two occurrences: primary outcome and stroke analysis).Extra parentheses are grammatical errors that should be corrected.
- 4.MEDIUMcopyeditFix the typo in the Results section: 'versus and 170 (17.5%)' should read 'versus 170 (17.5%)'.Typographical error obscures the comparison.
- 5.MEDIUMcopyeditClarify the Table 3 footnote about SctO2 baseline measurements to distinguish between baseline and intraoperative missing data.The current wording is ambiguous and could mislead readers.
- 6.MEDIUMcopyeditRemove the double parenthesis in the stroke analysis: '0.40 ((0.14 to 0.99)' should be '0.40 (0.14 to 0.99)'.Double parenthesis is a formatting error.
- 7.MEDIUMcopyeditAdd 'risk ratio' before the parentheses in the ancillary analysis stroke result: '...versus 13 (1.3%) of 964 patients (0.25 (0.06 to 0.76)...' should read '...risk ratio 0.25 (0.06 to 0.76)...'.Missing label reduces clarity.
- 8.MEDIUMreportingProvide a CONSORT flow diagram in the main text (currently only referenced as Figure 2) to show participant flow, including numbers screened and excluded at each stage.A flow diagram improves transparency and is a CONSORT requirement.
- 9.MEDIUMreportingReport the exact p-values for all secondary outcomes after Holm-Bonferroni adjustment in the main text, as some are only reported as 'P>0.99'.Exact p-values allow readers to assess the strength of evidence.
- 10.MEDIUMdata codeProvide the analysis code in a version-controlled public repository (e.g., GitHub) with a DOI, rather than only in supplemental files.Version-controlled code enhances reproducibility and long-term access.
- 11.MEDIUMdata codeAdd a data dictionary or codebook for the publicly available dataset to facilitate reuse.A codebook helps other researchers understand and use the data correctly.
- 12.LOWreportingExplicitly state adherence to the Declaration of Helsinki or ICH-GCP guidelines in the ethics section.While IRB approval is documented, explicit ethical framework adherence is good practice.
- 13.LOWreportingClarify the handling of missing primary outcome data in the main text, including the number of patients with missing data.Transparency about missing data strengthens the modified intention-to-treat analysis.
- 14.LOWreportingProvide more detail on the intervention protocol in the main text, as it currently relies heavily on a figure and supplementary materials.A self-contained description improves readability and reproducibility.
- 15.LOWreportingReport the results of any interim analyses in the main text, as they are only mentioned without details.Interim analysis results are important for assessing trial conduct.
The star rating is the report’s one-glance summary. Every paper starts at 5★ and loses stars for the concrete problems the review finds — so a rating is never a vague average, it’s a running total you can read line by line under “How this rating was calculated.”
- Reporting — 8 dimensionseach dimension that fully fails−½★
- each dimension partially met−¼★
- Statistics · Integrity · Claimseach serious problem−1★
- each medium problem−½★
- Citationseach retracted or unverifiable reference−¼★
- Copyeditonly when the manuscript needs a full edit−½★
The rating never drops below 1★, and a demonstrable critical failure (an impossible statistic, a proven ethics violation) caps it at 1★ on its own — so the stars can never look healthy when the verdict is CRITICAL.
The rating draws on a panel of agents. Three independent Kaimen Rigor reviewers grade the eight dimensions below across several independent passes (the shown verdict is their majority vote — steadier than any single run), isolate the paper’s major claims and check its own evidence backs them, and flag integrity concerns. Alongside them, a citation agent resolves every reference against Crossref, OpenAlex, and Retraction Watch; a statistics agent recomputes reported tests; and rule-based checks verify that declared data/code links actually resolve. Full text is required — an abstract-only submission is not analyzed.
Graded against NIH, MDAR, ARRIVE 2.0, CONSORT, EQUATOR, and RRID guidelines. A dimension that doesn’t apply to the study type is skipped, never penalized.
This Kaimen Rigor review is model-assisted and is not a substitute for formal expert review. It complements human evaluation by surfacing potential methodological concerns — verify each finding against the source.