Effect of lateral versus supine positioning on hypoxaemia in sedated adults: multicentre randomised controlled trial.
Ye H, Chu LH, Xie GH, Hua YJ, Lou Y, Wang QH, Xu ZX, Tang MY, Wang BD, Hu HY, Ying J, Yu T, Wang HY, Wang Y, Ye ZJ, Bao XF, Wang MC, Chen LY, Wang XX, Zhang XB, Huang CS, Wang J, Lu YP, Luo FQ, Zhou W, Wang CG, Cheng H, Liu WJ, Luo J, Wu YQ, Li RR, Wang D, Hou LQ, Shi L, Zhang J, Wang K, Pi X, Zhou R, Yang QQ, Wan PL, Li H, Wu SJ, Song SW, Cui P, Shu L, Islam N, Fang XM
- DOI
- 10.1136/bmj-2025-084539
- 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/e8b75c89-72e9-48c2-aa7a-ab52c908e8f2 is authoritative.
How this rating was calculated
- IntegrityIntegrity concern ×2−1★
- LinksDead data/code link−0.25★
- 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.
- 01Declared data/code link does not resolve
Dead link — nothing to verify.
“https://github.com/Huiye272/2025-hypoxaemia”
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 multicentre RCT with rigorous randomisation, adequate sample size, and comprehensive reporting of ethics, demographics, and data/code availability. The main weaknesses are minor reporting gaps: no explicit CONSORT checklist, a confusing sentence in the statistical analysis section, and a dead link in the data/code availability. Overall, the paper is methodologically sound with no major integrity concerns.
Both reviewers independently scored all eight dimensions and agreed on pass for each; no divergence required reconciliation. The statistics verification recomputed 7 tests consistently, but coverage is limited to tests with test statistics/df or effect estimates with CIs; threshold-only p-values and resampling-based tests were not verified. The citation check found no retracted or unresolved references. The reproducibility check found 1 of 2 links dead.
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 7 tests: 7 consistent, 0 inconsistent; 5 recomputed directly from the reported test statistics, 2 via agent-written checks.
- CONSISTENTreported p < .001 · recomputed p = <.001Recomputed risk ratio 0.36 (95% CI 0.27–0.49), reported p<0.001
“risk ratio 0.36, 95% confidence interval (CI) 0.27 to 0.49; P<0.001”
Taken as given: 0.27–0.49 is a two-sided 95% confidence interval for the risk ratio of 0.36, 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<0.001 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(0.36, 0.27, 0.49, 1) - CONSISTENTreported p < .001 · recomputed p = <.001Recomputed risk ratio 0.46 (95% CI 0.34–0.61), reported p<0.001
“risk ratio 0.46, 95% CI 0.34 to 0.61; P<0.001”
Taken as given: 0.34–0.61 is a two-sided 95% confidence interval for the risk ratio of 0.46, 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<0.001 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(0.46, 0.34, 0.61, 1) - CONSISTENTreported p < .001 · recomputed p = <.001Recomputed risk ratio 0.16 (95% CI 0.07–0.33), reported p<0.001
“risk ratio 0.16, 95% CI 0.07 to 0.33; P<0.001”
Taken as given: 0.07–0.33 is a two-sided 95% confidence interval for the risk ratio of 0.16, 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<0.001 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(0.16, 0.07, 0.33, 1) - CONSISTENTreported p = .004 · recomputed p = .005Recomputed risk ratio 0.65 (95% CI 0.48–0.87), reported p=0.004
“risk ratio 0.65, 95% CI 0.48 to 0.87; P=0.004”
Taken as given: 0.48–0.87 is a two-sided 95% confidence interval for the risk ratio of 0.65, 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=0.004 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(0.65, 0.48, 0.87, 1) - CONSISTENTreported p < .001 · recomputed p = <.001Recomputed risk ratio 0.45 (95% CI 0.34–0.58), reported p<0.001
“risk ratio 0.45, 95% CI 0.34 to 0.58; P<0.001”
Taken as given: 0.34–0.58 is a two-sided 95% confidence interval for the risk ratio of 0.45, 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<0.001 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(0.45, 0.34, 0.58, 1) - CONSISTENTreported p < .001 · recomputed p = <.001Reviewers 1, 2Lowest SpO2 mean difference p-value from CI
“absolute adjusted mean difference 1.20%, 95% CI 0.87% to 1.54%; P<0.001”
Taken as given: The mean difference is 1.20 with 95% CI 0.87 to 1.54.; The CI is two-sided at 95%.; The mean difference is approximately normally distributed.Method: Two-tailed p-value from mean difference and CI using normal approximation.How we recomputed it: pCI(1.20, 0.87, 1.54, 0) - CONSISTENTreported p = .002 · recomputed p = .002Reviewers 1, 2Length of stay mean difference p-value from CI
“absolute adjusted mean difference −2.22 minutes; 95% CI −3.63 to −0.80; P=0.002”
Taken as given: The mean difference is -2.22 with 95% CI -3.63 to -0.80.; The CI is two-sided at 95%.; The mean difference is approximately normally distributed.Method: Two-tailed p-value from mean difference and CI using normal approximation.How we recomputed it: pCI(-2.22, -3.63, -0.80, 0)
- lowinternal contradictionThe abstract states 2159 randomised and 2143 analysed, but the results section mentions 'Three patients did not complete follow-up' without specifying how this reconciles with the 16 excluded for ineligibility.
Among them, 16 patients (four in intervention arm and 12 in control arm) were later found to be ineligible (see supplementary table 7), and therefore 2143 patients were analysed: 1073 in the lateral group and 1070 in the supine group, all of whom were included in the intention-to-treat analysis. ... Three patients did not complete follow-up.
Resultsreviewer’s wording
Overstated conclusions
1 finding · worst lowConclusions 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.
- Conclusions only partially backed by the presented evidenceAssessed
9 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.
- partialReviewers 1, 2Lateral positioning could offer advantages in remote or resource constrained clinical settings.The claim is reasonable given the simplicity and low cost, but the trial was conducted in tertiary hospitals in China, not specifically in resource-constrained settings; generalisability to such settings is inferred.Evidence: The intervention is simple and low cost, but no direct evidence from resource-constrained settings is presented.
“Given its simplicity and low cost, lateral positioning could offer advantages in remote or resource constrained clinical settings.”
ConclusionFind in source - supportedReviewer 1Lateral positioning significantly reduces the incidence of hypoxaemia compared with supine positioning.The primary outcome analysis shows a significant reduction with adjusted risk ratio 0.36 (95% CI 0.27-0.49, P<0.001).Evidence: Primary outcome result: 5.4% vs 15.0%, adjusted RR 0.36, 95% CI 0.27-0.49, P<0.001.
“The incidence of hypoxaemia was significantly lower in the lateral group compared with supine group (5.4% (58/1073) v 15.0% (161/1070); adjusted risk ratio 0.36, 95% confidence interval (CI) 0.27 to 0.49; P<0.001).”
AbstractFind in source - supportedReviewers 1, 2Lateral positioning reduces the need for airway rescue interventions.Secondary outcome shows significant reduction with adjusted RR 0.46 (95% CI 0.34-0.61, P<0.001).Evidence: Airway rescue interventions: 6.3% vs 13.8%, adjusted RR 0.46, 95% CI 0.34-0.61, P<0.001.
“Compared with patients in the supine group, patients in the lateral group required fewer airway rescue interventions (6.3% (68/1073) v 13.8% (148/1070); adjusted risk ratio 0.46, 0.34 to 0.61; P<0.001)”
AbstractFind in source - supportedReviewers 1, 2Lateral positioning reduces the incidence of severe hypoxaemia.Secondary outcome shows significant reduction with adjusted RR 0.16 (95% CI 0.07-0.33, P<0.001).Evidence: Severe hypoxaemia: 0.7% vs 4.8%, adjusted RR 0.16, 95% CI 0.07-0.33, P<0.001.
“had a lower incidence of severe hypoxaemia (0.7% (8/1073) v 4.8% (51/1070); adjusted risk ratio 0.16, 0.07 to 0.33; P<0.001)”
AbstractFind in source - supportedReviewers 1, 2Lateral positioning improves the lowest oxygen saturation level.Secondary outcome shows significant improvement with mean difference 1.20% (95% CI 0.87-1.54, P<0.001).Evidence: Lowest SpO2: 96.9% vs 95.7%, adjusted mean difference 1.20%, 95% CI 0.87-1.54, P<0.001.
“had a higher mean lowest SpO 2 level (96.9% v 95.7%, absolute adjusted mean difference 1.20%, 95% CI 0.87% to 1.54%; P<0.001)”
AbstractFind in source - supportedReviewer 1Lateral positioning shortens length of stay in the post-anaesthesia care unit.Secondary outcome shows significant reduction with mean difference -2.22 minutes (95% CI -3.63 to -0.80, P=0.002).Evidence: Length of stay: 38.2 vs 40.5 minutes, adjusted mean difference -2.22, 95% CI -3.63 to -0.80, P=0.002.
“length of stay in the post-anaesthesia care unit was shorter in the lateral group (38.2 v 40.5 minutes; absolute adjusted mean difference −2.22 minutes; 95% CI −3.63 to −0.80; P=0.002)”
AbstractFind in source - supportedReviewers 1, 2Lateral positioning does not compromise safety.Safety outcomes were comparable between groups, with tachycardia less frequent in the lateral group; no significant differences in other safety outcomes.Evidence: Safety outcomes table shows no significant differences in bradycardia, hypotension, arrhythmia, cough, nausea/vomiting; tachycardia was lower in lateral group.
“Safety outcomes were comparable between the groups, but tachycardia was less frequent in the lateral group.”
ResultsFind in source - supportedReviewer 2Lateral positioning reduces the incidence of hypoxaemia in sedated adults.The primary outcome shows a significant reduction with a large effect size and narrow CI.Evidence: Primary outcome: 5.4% vs 15.0%, adjusted RR 0.36 (95% CI 0.27-0.49), P<0.001.
“The incidence of hypoxaemia was significantly lower in the lateral group compared with supine group (5.4% (58/1073) v 15.0% (161/1070); adjusted risk ratio 0.36, 95% confidence interval (CI) 0.27 to 0.49; P<0.001).”
AbstractFind in source - supportedReviewer 2Lateral positioning shortens PACU length of stay.Secondary outcome shows a significant reduction.Evidence: PACU stay: 38.2 vs 40.5 minutes, adjusted mean difference -2.22 (95% CI -3.63 to -0.80), P=0.002.
“length of stay in the post-anaesthesia care unit was shorter in the lateral group (38.2 v 40.5 minutes; absolute adjusted mean difference −2.22 minutes; 95% CI −3.63 to −0.80; P=0.002)”
AbstractFind in source
Efficacy claim is anchored to an adequate endpoint and a meaningful effect.
- ADEQUATESurrogate endpointThe primary outcome is incidence of hypoxaemia (SpO2 ≤90%), which is a direct clinical outcome, not a surrogate. The trial measures a hard clinical event (oxygen desaturation) and its consequences (airway rescue interventions, severe hypoxaemia).
“The primary outcome was incidence of hypoxaemia, defined as any occurrence of oxygen saturation (SpO2) ≤90% for at least five seconds during the initial 10 minute period after positioning”
- ADEQUATEEffect sizeThe effect size is large and clinically meaningful: lateral positioning reduced hypoxaemia incidence from 15.0% to 5.4% (adjusted risk ratio 0.36, absolute risk difference -9.15%, NNT 11). This is a substantial reduction in a clinically relevant outcome, with statistical significance and clear clinical benefit.
“The incidence of hypoxaemia was significantly lower in the lateral group compared with supine group (5.4% (58/1073) v 15.0% (161/1070); adjusted risk ratio 0.36, 95% confidence interval (CI) 0.27 to 0.49; P<0.001).”
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 mentions a discrepancy between the registered protocol and the manuscript due to translation, which could raise concerns about protocol adherence.
“Owing to the translation from Chinese to English, however, some discrepancies between the registered trial protocol on ClinicalTrials.gov and this manuscript exist.”
MethodsFind 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 studies on hypoxaemia incidence and the theoretical basis for lateral positioning, acknowledges that evidence is limited and derived mainly from small studies, and frames the trial as addressing this gap. Limitations of prior research are implicitly addressed by the large multicentre design, though not explicitly itemised.
“Hypoxaemia is a critical and potentially life threatening complication in sedated patients, with incidence rates ranging from 4% to 71%.”
“Lateral positioning theoretically mitigates these gravitational effects, but evidence supporting its application in routine clinical care is limited, derived mainly from small studies or in the context of specific procedures.”
“In this multicentre randomised controlled trial with a large sample of participants, we aimed to address this gap in knowledge.”
“Hypoxaemia is a critical and potentially life threatening complication in sedated patients, with incidence rates ranging from 4% to 71%.”
“Despite these promising observations, the effect of lateral positioning on prevention of hypoxaemia in sedated adults remains unclear. In this multicentre randomised controlled trial with a large sample of participants, we aimed to address this gap in knowledge.”
“evidence supporting its application in routine clinical care is limited, derived mainly from small studies or in the context of specific procedures.”
Randomisation used permuted blocks of four, stratified by centre, with computer-generated codes and opaque sealed envelopes. Sample size was estimated with 90% power to detect a 50% difference. Inclusion/exclusion criteria are detailed. Blinding was not feasible (open-label) but the primary outcome was objectively recorded by pulse oximetry. Outlier handling is addressed through ITT analysis and pre-specified analysis population. Controls are inherent in the comparator arm. Independent replication is not applicable for a single pivotal trial.
“they were randomly assigned in a 1:1 ratio to receive either lateral positioning or supine positioning using permuted blocks of four, stratified by study centre.”
“We estimated the required study sample size with 90% power at a two sided significance level of 5% to detect a 50% difference in incidence of hypoxaemia (8% in supine group and 4% in lateral group).”
“Blinding was not feasible owing to the nature of the intervention; however, outcomes were objectively assessed to minimise bias.”
“they were randomly assigned in a 1:1 ratio to receive either lateral positioning or supine positioning using permuted blocks of four, stratified by study centre. An independent statistician not involved in study implementation provided randomisation sequences using computer generated codes. Allocation concealment was maintained through sequentially numbered, opaque, sealed envelopes opened immediately before implementation of the intervention.”
“We estimated the required study sample size with 90% power at a two sided significance level of 5% to detect a 50% difference in incidence of hypoxaemia (8% in supine group and 4% in lateral group).”
“Blinding was not feasible owing to the nature of the intervention; however, outcomes were objectively assessed to minimise bias.”
The paper reports sex (53.7% women), age (mean 53.1 years), BMI, weight, height, comorbidities, and ASA status in Table 1. Since both sexes are enrolled, sex_justified is not applicable. Species/strain and housing conditions are not applicable for a human trial.
“The mean age of the patients was 53.1 years (SD 14.9) years, mean BMI was 23.9 (SD 3.4), and 53.7% (1150/2143) were women.”
“Chronic conditions | 654 (30.5) | 315 (29.4) | 339 (31.7)”
“53.7% (1150/2143) were women.”
“Mean (SD) age (years) | 53.1 (14.9) | 52.7 (14.9) | 53.5 (15.0)”
“Chronic conditions | 654 (30.5) | 315 (29.4) | 339 (31.7)”
The protocol was approved by the institutional review board of the First Affiliated Hospital, School of Medicine, Zhejiang University (approval No 2024-043) and other centres. All participants provided written informed consent preoperatively. The protocol adhered to the Declaration of Helsinki.
“This trial was approved by the institutional review board of The First Affiliated Hospital, School of Medicine, Zhejiang University (approval No 2024-043) and other participating centres.”
“All participants provided written informed consent preoperatively.”
“The protocol adhered to the Declaration of Helsinki.”
“This trial was approved by the institutional review board of The First Affiliated Hospital, School of Medicine, Zhejiang University (approval No 2024-043) and other participating centres.”
“All participants provided written informed consent preoperatively.”
“The protocol adhered to the Declaration of Helsinki.”
The intervention is a positioning manoeuvre, not a drug or device. The paper describes the positioning procedure in detail. No antibodies, cell lines, or organisms are used. Software used for analysis (STATA/MP 16.0) is identified. Therefore, the applicable criteria are limited to software identification, which is adequate.
“Statistical analyses were conducted using STATA/MP version 16.0 (StataCorp).”
“Patients allocated to lateral positioning were placed at 90° on a horizontal bed, supported with a pillow to maintain neutral alignment of the spine and avoid hyperextension or forward flexion of the neck.”
“Statistical analyses were conducted using STATA/MP version 16.0 (StataCorp).”
The paper names the tests (Poisson regression, linear regression, binary regression) and provides exact p-values and 95% CIs. Effect sizes are reported with CIs. Software is identified. Data presentation includes per-group n and dispersion. Mathematical plausibility checks on reported percentages and counts were consistent (e.g., 5.4% of 1073 = 58).
“For the primary outcome, we used a Poisson regression model adjusting for study sites to estimate risk ratios and corresponding 95% confidence intervals (CIs).”
“adjusted risk ratio 0.36, 95% CI 0.27 to 0.49; P<0.001”
“For the primary outcome, we used a Poisson regression model adjusting for study sites to estimate risk ratios and corresponding 95% confidence intervals (CIs).”
“adjusted risk ratio 0.36, 95% CI 0.27 to 0.49; P<0.001”
“Risk ratio (95% CI) | 0.36 (0.27 to 0.49) | <0.001”
The data availability statement provides a Synapse DOI and a GitHub repository for code. Access to data is governed by a data use agreement, which is appropriate for patient-level data. Repository deposit and accession numbers are applicable and adequate.
“The data underlying the findings of this paper are available in Synapse ( https://doi.org/10.7303/syn66534226 ).”
“The codes used to analyse the data can be found in the supplementary files and GitHub ( https://github.com/Huiye272/2025-hypoxaemia ).”
“The data underlying the findings of this paper are available in Synapse ( https://doi.org/10.7303/syn66534226 ).”
“The codes used to analyse the data can be found in the supplementary files and GitHub ( https://github.com/Huiye272/2025-hypoxaemia ).”
Trial registration number is provided (NCT06459167). Methods are comprehensive. Limitations are explicitly discussed. Conclusions are proportional. Funding and COI are stated. A reporting guideline is not explicitly referenced, but the manuscript follows standard RCT reporting.
“Trial registration ClinicalTrials.gov NCT06459167 .”
“This trial has several limitations. Firstly, the open label design could introduce observer or performance bias.”
“Funding: This study was funded by the National Natural Science Foundation of China (No U24A20714 to X-MF; No 82302425 to HY; No 82072148 to G-HX).”
“Trial registration ClinicalTrials.gov NCT06459167 .”
“Funding: This study was funded by the National Natural Science Foundation of China (No U24A20714 to X-MF; No 82302425 to HY; No 82072148 to G-HX).”
“This trial has several limitations. Firstly, the open label design could introduce observer or performance bias.”
Registered (1 ID: ClinicalTrials.gov). No reporting guideline cited.
Broken references and links
1 finding · worst mediumReferences 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.
- Dead data/code linksRecomputed
Checked 73 references by DOI: 73 verified.
Every extracted reference resolved against Crossref/OpenAlex with no retraction flags.
2 data/code links checked; 1 live, 1 dead.
- datahttps://doi.org/10.7303/syn66534226LIVEHTTP 200Resolves, but the content could not be matched to the paper.
- codeGitHubDEADHTTP 404https://github.com/Huiye272/2025-hypoxaemiaDead link — nothing to verify.
Copyediting
6 minorWording, consistency and formatting errors that need correcting before submission.
No major wording or formatting errors. 6 minor suggestions below.
6 copyedit issues flagged: mostly typo, consistency, grammar.
- MINORtypoAbstract, Results“53.7% (1150/2143) were women”→ Consider rephrasing to 'were women' is fine; no change needed.No issue found.
- MINORconsistencyMethods, Statistical analysis“No formal statistical analysis was conducted in accordance with established reporting guidelines.”→ This sentence is confusing; likely meant 'No formal sample size re-estimation was conducted' or similar. Clarify.Ambiguous sentence that could be misinterpreted.
- MINORgrammarDiscussion, Strengths and limitations“by showing it is effective under everyday clinical circumstances increased the likelihood”→ Change to 'by showing it is effective under everyday clinical circumstances, we increased the likelihood'.Run-on sentence.
- MINORtypoAbstract, Results“adjusted risk ratio 0.36, 95% confidence interval (CI) 0.27 to 0.49; P<0.001”→ Ensure consistent use of 'P' vs 'p' for p-values.Inconsistent capitalization of p-value.
- MINORconsistencyMethods, Statistical analysis“No formal statistical analysis was conducted in accordance with established reporting guidelines.”→ This sentence is confusing; clarify that no formal statistical analysis plan was published, or rephrase.Ambiguous sentence.
- MINORgrammarDiscussion, Strengths and limitations“by showing it is effective under everyday clinical circumstances increased the likelihood that our findings can be translated directly into practice.”→ Rephrase to 'by showing it is effective under everyday clinical circumstances, we increased the likelihood...'Awkward phrasing.
The published work is robust and trustworthy, with no major rigor gaps. An informed reader should weigh the minor reporting issues: the missing explicit CONSORT checklist, the ambiguous sentence in the statistical analysis section, the dead link in the data/code availability, and the small internal contradiction in participant numbers. These do not undermine the conclusions but warrant clarification or correction.
- 1.HIGHreportingAdd an explicit statement of adherence to CONSORT reporting guidelines and provide the CONSORT checklist as supplementary material.Both reviewers flagged the absence of an explicit reporting guideline, which is a standard expectation for RCTs and improves transparency.
- 2.HIGHdata codeFix the dead link in the data/code availability (the GitHub repository or Synapse DOI that returned a dead link) and verify all links are live.A broken link undermines the data/code availability statement and prevents readers from accessing the materials.
- 3.HIGHreportingClarify the discrepancy between the registered protocol and the manuscript in the main text, not just in supplementary material.The integrity check noted a protocol discrepancy due to translation; clarifying it in the main text avoids confusion about protocol adherence.
- 4.MEDIUMreportingClarify the participant flow: reconcile the numbers 2159 randomised, 2143 analysed, and the 16 excluded for ineligibility, and specify how the 'three patients did not complete follow-up' fit into this.The integrity check flagged a low-severity internal contradiction that could confuse readers about the analysis population.
- 5.MEDIUMcopyeditRephrase the sentence in Methods, Statistical analysis: 'No formal statistical analysis was conducted in accordance with established reporting guidelines.' to clarify its intended meaning (e.g., 'No formal sample size re-estimation was conducted').The copyedit pass flagged this as ambiguous and potentially misleading.
- 6.MEDIUMcopyeditFix the run-on sentence in Discussion, Strengths and limitations: 'by showing it is effective under everyday clinical circumstances increased the likelihood' to 'by showing it is effective under everyday clinical circumstances, we increased the likelihood'.The copyedit pass flagged this as a grammatical error that affects readability.
- 7.MEDIUMcopyeditStandardize the capitalization of p-values (e.g., use 'P' consistently or 'p' consistently) throughout the manuscript.The copyedit pass noted inconsistent capitalization of p-value, which is a minor consistency issue.
- 8.LOWreportingAdd a statement on whether any interim analyses were planned or conducted in the Methods.Reviewer 2 suggested this as a completeness improvement for trial reporting.
- 9.LOWreportingSpecify the exact version of the Declaration of Helsinki adhered to (e.g., 2013 version) in the Methods or Ethics section.Both reviewers suggested this to improve regulatory compliance reporting.
- 10.LOWdata codeProvide the full data use agreement terms in the data availability statement or as supplementary material.Reviewer 2 suggested this to make access conditions fully transparent.
- 11.LOWdata codeConsider adding a version-controlled repository with a DOI for the statistical analysis code, in addition to the GitHub link.Reviewer 2 suggested this to ensure long-term code availability and citability.
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.