Risk of infection and wound dehiscence after use of prophylactic antibiotics in episiotomy or second degree tear (REPAIR study): single centre, double blind, placebo controlled randomised trial.
Perslev K, Klarskov N, Bergholt T, Jangö H
- DOI
- 10.1136/bmj-2025-084312
- Record issued
- 2026-08-10
- Engine
- 7.29.0
- Exported
- 2026-09-21
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/fa3a9a8f-8e64-4982-a9b1-297587e0b02d is authoritative.
- Only 2 of 3 reviewers completed. Each verdict below is the majority of 2, not of 3 — the disagreement between reviewers that normally filters out one model's noise could not be applied.
- This run hit its time budget: at least one step billed work that never produced a result.
How this rating was calculated
- IntegrityIntegrity concern ×2−1★
- ReportingKey resources partially met−0.25★
- ReportingStatistical analysis partially met−0.25★
- ReportingData & code availability partially met−0.25★
- 01Other integrity concern
Trial NCT05830162 was first submitted to ClinicalTrials.gov on 2023-03-29, after the registered study start date of 2023-03-21. Retrospective registration means the protocol and outcomes were not on the public record before the study ran, which is what prospective registration exists to establish.
NCT05830162
reviewer’s wording
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.
The REPAIR trial is a methodologically strong, well-designed double-blind placebo-controlled RCT with rigorous randomisation, blinding, power analysis, transparent reporting, dual registration, CONSORT adherence, and openly available data. The main weaknesses are reporting gaps rather than validity threats: the investigational drug manufacturer is not stated, one p-value is reported only as a threshold, the analysis code is only in supplemental files, and registration was retrospective with the headline recommendation resting on a secondary outcome added after study initiation.
Two independent reviewer runs were reconciled; they agreed on six dimensions and diverged on statistical analysis (warn vs pass) and on the demographics sub-criterion (ethnicity). The statistics verification recomputed only 4 tests reported with test statistics/df or effect estimates with CIs (all consistent); threshold-only, exact/permutation p-values and GRIM/GRIMMER checks (inapplicable to continuous measurements) are not verified. All 22 references were located with none retracted, and both data links are live. Criteria not applicable to a human obstetric drug trial were excluded.
Numerical inconsistencies
None foundValues 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.
Checked — nothing surfaced.
Recomputed 4 tests: 4 consistent, 0 inconsistent; 4 via agent-written checks.
- CONSISTENTreported p = .100 · recomputed p = .097Reviewer 1Primary outcome wound complications: Fisher's exact test on antibiotic vs placebo event counts
“No significant difference was observed in overall wound complications (antibiotic 47/218, 22%; placebo 62/215, 29%; P=0.10)”
Taken as given: The 47 and 62 are the event counts in the antibiotic and placebo groups, respectively; The 218 and 215 are the group totals, so non-events are 171 and 153; Fisher's exact test was used as stated in the methods; The p-value is two-tailedMethod: Two-tailed Fisher's exact test on the 2x2 contingency table (47,171,62,153).How we recomputed it: pFisher2x2(47,171,62,153,0) - CONSISTENTreported p = .010 · recomputed p = .014Reviewers 1, 2Secondary outcome clinically relevant wound complications: Fisher's exact test
“For clinically relevant wound complications, significantly fewer events occurred in the treatment group (19/218, 9% v 36/215, 17%; P=0.01)”
Taken as given: The 19 and 36 are the event counts in the antibiotic and placebo groups, respectively; The 218 and 215 are the group totals, so non-events are 199 and 179; Fisher's exact test was used as stated in the methods; The p-value is two-tailedMethod: Two-tailed Fisher's exact test on the 2x2 contingency table (19,199,36,179).How we recomputed it: pFisher2x2(19,199,36,179,0) - CONSISTENTreported p = .040 · recomputed p = .044Reviewer 1Exploratory outcome 'Antibiotics before REPAIR visit': Fisher's exact test
“Antibiotics before REPAIR visit | 4 (1.9) | 12 (5.6) | 0.04”
Taken as given: The 4 and 12 are the event counts in the antibiotic and placebo groups, respectively; The 218 and 215 are the group totals, so non-events are 214 and 203; Fisher's exact test was used as stated in the methods; The p-value is two-tailedMethod: Two-tailed Fisher's exact test on the 2x2 contingency table (4,214,12,203).How we recomputed it: pFisher2x2(4,214,12,203,0) - CONSISTENTreported p = .100 · recomputed p = .097Reviewer 2Primary outcome (wound complications): two-tailed Fisher's exact test comparing 47/218 (antibiotic) vs 62/215 (placebo), as reported in Table 2.
“| Primary outcome | | Wound complications* | 47 (21.6) | 62 (28.8) | 0.10 | −7.2 (−15.4 to 0.8) | 0.75 (0.54 to 1.04) |”
Taken as given: 47 and 62 are the event counts in the antibiotic (n=218) and placebo (n=215) groups respectively; non-event counts of 171 and 153 are derived from the group totals (218-47 and 215-62); the paper used Fisher's exact test for categorical variables, two-tailedMethod: Two-tailed Fisher's exact test on the 2×2 table (47,171,62,153).How we recomputed it: pFisher2x2(47,171,62,153)
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
7 major claims checked against the paper's own evidence: all adequately supported.
- partialReviewer 1The findings provide evidence to support updating postpartum care guidelines.The significant secondary outcome provides some evidence, but the primary outcome was non-significant and the exploratory outcomes were not pre-specified, so the evidence is not conclusive for a guideline change.Evidence: Discussion and Conclusion: The conclusion recommends consideration of antibiotics based on the secondary outcome.
“This finding supports the use of prophylactic antibiotics in routine clinical practice after a second degree tear or episiotomy.”
ConclusionFind in source - partialReviewers 1, 2The protective effect of prophylactic antibiotics is also significant in low risk populations (BMI <30, non-instrumental delivery, no episiotomy).The claim is backed only by a post hoc subgroup analysis (P<0.05 in all three subanalyses), which was not prespecified, so it is suggestive but not confirmatory.Evidence: Post hoc subgroup analysis in supplementary file S4 showing P<0.05 in all three subanalyses.
“Post hoc subgroup analysis of women without high risk variables (body mass index ≥30, instrumental delivery, or episiotomy) showed a consistently significant effect (P<0.05 in all three subanalyses)”
ResultsFind in source - partialReviewer 2Prophylactic antibiotics should be considered/used in routine clinical practice after a second degree tear or episiotomy.The recommendation extends from a significant secondary outcome while the primary outcome was null, and the secondary outcome was registered after study initiation; the paper is transparent about this but the clinical recommendation reaches beyond the primary evidence.Evidence: Secondary outcome significant (P=0.01); primary outcome non-significant (P=0.10); secondary outcome added to registry after initiation.
“This finding supports the use of prophylactic antibiotics in routine clinical practice after a second degree tear or episiotomy.”
ConclusionFind in source - supportedReviewer 1Prophylactic antibiotics significantly reduced the risk of clinically relevant wound complications.The secondary outcome showed a significant reduction (P=0.01, RR 0.52, 95% CI 0.31 to 0.88), directly supporting the claim.Evidence: Table 2 and Abstract: 19/218 (9%) vs 36/215 (17%), P=0.01, risk difference -8.0% (95% CI -14.3 to -1.8).
“For clinically relevant wound complications, significantly fewer events occurred in the treatment group (19/218, 9% v 36/215, 17%; P=0.01)”
Table 2Find in source - supportedReviewer 1Although no significant effect was seen for overall wound complications, prophylactic antibiotics significantly reduced the risk of clinically relevant wound complications.The primary outcome was non-significant (P=0.10) and the secondary outcome was significant (P=0.01), matching the claim exactly.Evidence: Abstract Results: primary P=0.10, secondary P=0.01.
No significant difference was observed in overall wound complications (antibiotic 47/218, 22%; placebo 62/215, 29%; P=0.10)... For clinically relevant wound complications, significantly fewer events occurred in the treatment group (19/218, 9% v 36/215, 17%; P=0.01)
Abstractreviewer’s wording - supportedReviewer 2Prophylactic antibiotics significantly reduced the risk of clinically relevant wound complications in women with episiotomies and second degree tears.The presented evidence (19/218 vs 36/215, P=0.01, RR 0.52, 95% CI 0.31-0.88) directly backs this claim.Evidence: Table 2 secondary outcome: 19 (8.7) vs 36 (16.7), P=0.01, risk difference −8.0% (−14.3 to −1.8), RR 0.52 (0.31 to 0.88).
“prophylactic antibiotics significantly reduced the risk of clinically relevant wound complications in women with episiotomies and second degree tears”
ConclusionFind in source - supportedReviewer 2No significant effect was seen for overall wound complications.The primary outcome was non-significant (P=0.10), matching the claim.Evidence: Table 2 primary outcome: 47 (21.6) vs 62 (28.8), P=0.10.
“Although no significant effect was seen for overall wound complications”
ConclusionFind in source
Efficacy claim is anchored to an adequate endpoint and a meaningful effect.
- N/ASurrogate endpointThe primary and secondary outcomes are direct clinical events (wound dehiscence, wound infection, clinically relevant wound complications), not surrogate biomarkers.
“Primary outcome was wound dehiscence or wound infection (or both; hereafter referred to collectively as wound complications)... secondary outcome—clinically relevant wound dehiscence... categorised as clinically relevant if it required clinical follow-up because of the extent of the dehiscence (typically ≥10 mm), severity of pain, or infection.”
- ADEQUATEEffect sizeThe secondary outcome showed a significant reduction from 17% to 9% (NNT 12), which is clinically meaningful and anchored to a relevant clinical endpoint.
“clinically relevant wound complications were significantly reduced (9% v 17%, P=0.01)... number needed to treat was 12 (95% CI 7 to 56).”
Data authenticity concerns
1 finding · worst mediumAn 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).
- mediumotherTrial NCT05830162 was first submitted to ClinicalTrials.gov on 2023-03-29, after the registered study start date of 2023-03-21. Retrospective registration means the protocol and outcomes were not on the public record before the study ran, which is what prospective registration exists to establish.
NCT05830162
reviewer’s wording - lowotherThe headline conclusion supporting routine prophylactic antibiotic use rests on the secondary outcome (clinically relevant wound complications), which was added to the registry after study initiation, while the primary outcome was non-significant. The authors disclose this transparently, so it is a mild design/reporting consideration rather than evidence of misconduct.
“One limitation is that the outcome of clinically relevant wound dehiscence was registered at ClinicalTrials.gov after study initiation, although it was defined before study initiation and assessed prospectively throughout.”
LimitationsFind in source
Reporting gaps
3 findings · worst highRequired detail the manuscript never states — study design, biological variables, ethics approval and consent, key resources, statistical reporting, data and code availability, and overall transparency.
- Statistical reporting gaps (tests, assumptions, effect sizes)Assessed
- Data/code availability incompleteAssessed
- Key resources under-identified (antibodies, cell lines, RRIDs)Assessed
Prior work is cited with explicit acknowledgment of limitations (e.g., high loss to follow-up, lack of placebo control, methodological weaknesses). The rationale linking the evidence gap to the study objective is explicit, and the design addresses prior limitations (e.g., placebo control, defined outcomes, low drop-out rate).
“A Cochrane review evaluated prophylactic antibiotics for obstetric anal sphincter injury, but included only one randomised controlled trial, which reported a reduction in healing complications from 24% to 8% following a single intravenous dose of antibiotics. The loss to follow-up was high, prompting the authors to recommend cautious data interpretation.”
“Even less data are available on the effect of prophylactic antibiotics after the most common obstetric tears: episiotomies and second degree tears.”
“A 2017 Cochrane review evaluated antibiotic use after episiotomy but included only one study with methodological limitations. The review concluded that evidence was not sufficient to recommend prophylactic antibiotic use.”
“The REPAIR study evaluated whether three doses of prophylactic oral amoxicillin (500 mg) and clavulanic acid (125 mg) during the first day post partum could reduce wound dehiscence or infection (or both) following episiotomy or second degree tear regardless of mode of vaginal delivery.”
All applicable design elements are adequately reported: randomisation method (computer-generated variable block sizes), randomisation unit (participant), blinding (double-blind, with detailed measures to maintain blinding despite packaging differences), a priori sample size calculation (based on 50% reduction, alpha 0.05, power 80%, 10% drop-out), and inclusion/exclusion criteria. Outlier handling is addressed through ITT, per-protocol, and extreme-case sensitivity analyses. Replicate distinction, controls, and independent replication are not applicable for a human RCT.
“The Capital Region Pharmacy conducted randomisation using a computer generated random number sequence (1:1 allocation) in variable block sizes of six, eight, 10, and 12.”
“Physicians, the steering committee, and participants were blinded.”
“Accounting for an anticipated drop-out rate of 10%, a significance level of 0.05, and a power of 80%, the study required 442 women for inclusion, with a 1:1 allocation ratio.”
“The Capital Region Pharmacy conducted randomisation using a computer generated random number sequence (1:1 allocation) in variable block sizes of six, eight, 10, and 12.”
“Physicians, the steering committee, and participants were blinded.”
“Accounting for an anticipated drop-out rate of 10%, a significance level of 0.05, and a power of 80%, the study required 442 women for inclusion, with a 1:1 allocation ratio.”
Sex is reported (all participants are postpartum women). Age, weight (BMI) and health status are reported in Table 1 (e.g., mean age 31 vs 32 years, median BMI 22.8 vs 23.1, gestational diabetes, hypertension). Demographics include age, parity, BMI, and comorbidities; ethnicity was not collected, which the authors explicitly disclose as a limitation. Sex justification is n/a because the condition (obstetric tears) affects only women. Species/strain and housing are n/a for a human trial.
“Mean (SD) age (years) | 0 | 31 (4.6) | 32 (4.1)”
“Generalisability may be limited and selection bias introduced because of the single centre design, inclusion restricted to Danish-speaking women, and lack of ethnicity data.”
“Mean (SD) age (years) | 0 | 31 (4.6) | 32 (4.1)”
“This information included maternal age, parity, body mass index, gestational diabetes, pre-eclampsia, and previous or current psychological difficulties”
The ethical approval statement names the competent authorities (Danish Medicines Agency and the Danish National Committee on Health Research Ethics) via the EU CTIS system, with a protocol number. Written informed consent is explicitly stated. Regulatory compliance is evidenced by monitoring by the Danish Good Clinical Practice Unit and adherence to CONSORT.
“The trial was approved in Denmark through the EU Clinical Trials Information System (CTIS; EU No 2022-501930-49-00) by the Danish Medicines Agency and the Danish National Committee on Health Research Ethics.”
“All participants provided written informed consent.”
“the study was monitored by the national Danish Good Clinical Practice Unit”
“The trial was approved in Denmark through the EU Clinical Trials Information System (CTIS; EU No 2022-501930-49-00) by the Danish Medicines Agency and the Danish National Committee on Health Research Ethics.”
“All participants provided written informed consent.”
The drug is described with formulation (oral), strength (500 mg amoxicillin + 125 mg clavulanic acid), and dose regimen (three doses at 8-hour intervals), and the placebo is described as calcium tablets. However, no manufacturer or source is specified for either the drug or placebo. The statistical software (R Studio version 4.4.1) is identified. Antibodies, cell lines, mycoplasma, and organisms are not applicable in this clinical trial. Therefore, 1 of 2 applicable criteria is adequate.
“We used R Studio version 4.4.1 to perform statistical analyses.”
“The treatment group received three doses of oral antibiotics: amoxicillin (500 mg) with clavulanic acid (125 mg).”
“We used R Studio version 4.4.1 to perform statistical analyses.”
All applicable statistical elements are adequate except exact_p_values: the paper reports most p-values exactly (e.g., P=0.10, P=0.01), but uses '<0.001' for the wound dehiscence median difference. Tests are named (Fisher's exact, t-test, Mann-Whitney U), assumptions are checked via histograms and Q-Q plots, effect sizes with 95% CIs are presented, software is identified, and data presentation includes per-group n and CIs. No arithmetic errors were found in the reported percentages and risk differences.
“We used Fisher’s exact test for categorical variables while continuous variables were analysed using the t test when normally distributed and using the Mann-Whitney U test when not normally distributed.”
“Median (IQR) wound dehiscence (mm) | 7 (6-10) | 10 (7-12) | <0.001”
“with a risk difference of −7.2% (95% confidence interval (CI) −15.4% to 0.8%) and a relative risk of 0.75 (0.54 to 1.04).”
“We also calculated the risk difference, relative risk, and number needed to treat with 95% confidence intervals (CIs).”
The data availability statement names a concrete repository (dataverse.deic.dk) with a persistent identifier (DOI), and the data are openly available. However, the code is described as being in 'supplemental files,' which does not meet the standard of a version-controlled public repository with a permanent identifier. Since 2 of 3 applicable criteria are adequate, the dimension is rated warn.
“The data underlying the findings in this paper are openly and publicly available and can be found here: https://dataverse.deic.dk/dataset.xhtml?persistentId=doi:10.60612/DATADK/WTK5BD”
“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: https://dataverse.deic.dk/dataset.xhtml?persistentId=doi:10.60612/DATADK/WTK5BD”
“The code used to analyse the data in the paper can be found in the supplemental files.”
Methods are comprehensive and reference a protocol paper. Trial registration numbers for both EU-CTIS and ClinicalTrials.gov are given. The paper adheres to CONSORT 2010. All pre-specified outcomes (primary, secondary, exploratory) are reported, including non-significant results, and limitations are explicitly discussed. Conclusions are proportional to the evidence, acknowledging the primary outcome was non-significant. Funding and competing interests are declared.
“Trial registration Clinical Trials Information System (euclinicaltrials.eu) 2022-501930-49-00 and ClinicalTrials.gov NCT05830162”
“the present study adheres to the CONSORT 2010 guidelines.”
“One limitation is that the outcome of clinically relevant wound dehiscence was registered at ClinicalTrials.gov after study initiation, although it was defined before study initiation and assessed prospectively throughout.”
“Clinical Trials Information System (euclinicaltrials.eu) 2022-501930-49-00 and ClinicalTrials.gov NCT05830162”
“Generalisability may be limited and selection bias introduced because of the single centre design, inclusion restricted to Danish-speaking women, and lack of ethnicity data.”
“The study was funded by the Research Unit and the Department of Gynaecology and Obstetrics at Herlev Hospital.”
Registered (1 ID: ClinicalTrials.gov). Reporting guideline cited: CONSORT.
Broken references and links
None foundReferences 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 22 references by DOI: 17 verified — 5 no DOI (shown, not verified).
- NO DOIClinical evaluation of the chloramphenicol use as a prophylactic antibiotic in the vaginal delivery with episiotomyNo DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
- NO DOICould subcutaneous rifampicin administration be an effective approach for reducing episiotomy infections?No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
- NO DOICDC/NHSN Surveillance Definitions for Specific Types of Infections: Surveillance DefinitionsNo DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
- NO DOIRStudioNo DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
- NO DOILactogenesis: The transition from pregnancy to lactation: Breastfeeding 2001, Part I: The evidence for breastfeedingNo DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
2 data/code links checked; 2 live.
- dataDataverseLIVEHTTP 200https://dataverse.deic.dk/dataset.xhtml?persistentId=doi:10.60612/DATADK/WTK5BDResolves to Dataverse (data repository).
- datahttps://clinicaltrials.gov/ct2/show/NCT05830162LIVEHTTP 200Resolves, but the content could not be matched to the paper.
Copyediting
4 minorWording, consistency and formatting errors that need correcting before submission.
No major wording or formatting errors. 4 minor suggestions below.
4 copyedit issues flagged: mostly consistency, clarity, other.
- MINORconsistencyTable 1, Fetal presentation“Occiput anterior 14 | 199 (93.9) | 198 (95.6)”→ Verify that the missing count (14) is consistent with the reported counts (199 and 198) and the total n.The missing-information count for fetal presentation appears inconsistent with the reported counts (199+11+2=212 vs 218-14=204). This may be a table formatting issue.
- MINORclarityMethods, Drug treatment and side effects“According to Danish prescribing guidelines, no dose adjustment is required for treatment duration of less than one week regardless of kidney function.”→ Clarify whether this applies to the specific drug combination and whether any renal function assessment was performed.The statement is a general guideline; it may be clearer to specify the drug and the population.
- MINORconsistencyTable 1, Fetal presentation“| Occiput posterior | 11 (5.2) | 8 (3.9) |”→ Populate the 'No of participants with missing information' column for the occiput posterior and breech rows, consistent with the occiput anterior row showing 14.The missing-information column is blank for these rows, creating an apparent inconsistency with the occiput anterior row.
- MINORotherHeader“391 e084312 e084312”→ Remove the stray page/article identifier artifact from the header.Appears to be a typesetting artifact rather than a substantive error.
As a post-publication audit, the published REPAIR trial is robust: the design, ethics, transparency, and open data are strong, and no detected issue invalidates the reported results. An informed reader should weigh the retrospective registration timing, the recommendation carried by a secondary outcome added after initiation while the primary was non-significant, the missing drug manufacturer/source, and the single threshold-only p-value; none warrant a formal correction of the results, and the open data and code enable independent re-analysis.
- 1.HIGHreportingClarify in the trial-registration section why NCT05830162 was first submitted to ClinicalTrials.gov on 2023-03-29, after the registered study start date of 2023-03-21, and state plainly whether registration was prospective.Retrospective registration undermines the prospective-registration guarantee that the protocol and outcomes were fixed on the public record before the study ran.
- 2.HIGHdata codeDeposit the analysis code in a version-controlled public repository (e.g., GitHub or Zenodo) with a persistent DOI and cite it in the Data availability statement instead of only supplemental files.Code in supplemental files lacks version control and a permanent identifier, limiting reproducibility.
- 3.HIGHreportingSpecify the manufacturer/source and lot numbers of the amoxicillin/clavulanic acid and the placebo (calcium) tablets in Methods/Intervention.The investigational product is currently identified only by name, strength and regimen, which is an incomplete resource identification.
- 4.MEDIUMstatisticsReplace the threshold-only p-value '<0.001' for wound dehiscence in Table 2 with the exact computed value.A p-value the authors computed should be reported exactly rather than as a threshold; this is the sole imprecise-reporting element in the statistics.
- 5.MEDIUMreportingReport the exact post-partum timing of the first antibiotic/placebo dose, or state explicitly that it was not recorded and discuss the implication for efficacy interpretation.The Discussion notes the exact timepoint was not recorded, which is relevant to interpreting the treatment effect.
- 6.MEDIUMcopyeditFix Table 1 fetal-presentation rows: populate the 'No of participants with missing information' column for occiput posterior and breech rows, and reconcile the occiput anterior missing count (14) with the reported counts (199+11+2=212 vs 218−14=204).The blank column and the count discrepancy create an apparent internal inconsistency that a reader could construe as an error.
- 7.MEDIUMstatisticsState in Methods/Statistical analysis whether any multiple-testing correction was applied to the exploratory outcomes.The exploratory outcomes are numerous and not pre-specified, so readers need to know whether multiplicity was addressed.
- 8.MEDIUMreportingAdd race/ethnicity data to Table 1 if available, or make the absence and its impact on generalisability more prominent in the limitations.Ethnicity was not collected and the population was restricted to Danish-speaking women, limiting generalisability.
- 9.MEDIUMreportingQualify the routine-practice recommendation for prophylactic antibiotics, which rests on a secondary outcome added to the registry after study initiation while the primary outcome was non-significant.A headline conclusion carried by a post-hoc-added secondary outcome should be tempered to what the primary evidence supports.
- 10.LOWcopyeditRemove the stray header artifact '391 e084312 e084312'.It is a typesetting artifact rather than a substantive error, but it should be cleaned for a polished record.
- 11.LOWcopyeditClarify the kidney-function statement in Methods/Drug treatment to specify that no dose adjustment applies to amoxicillin/clavulanic acid for courses under one week and whether renal function was assessed.The statement is a general guideline and would be clearer if tied to the specific drug and population.
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.