Low-plastic diet and urinary levels of plastic-associated phthalates and bisphenols: the randomized controlled PERTH Trial.
Harray AJ, Lucas AD, Herrmann SE, Vlaskovsky PS, Elagali A, Seewoo BJ, Chan DC, Chiarugi D, Kulkarni R, Trevenen M, Wang X, Mueller J, Thomas KV, Papendorf H, Miller C, Gaudieri S, Smith T, Salman S, Murray K, Symeonides C, Dunlop SA, Watts GF, PERTH Trial Consortium, Lucas M
- DOI
- 10.1038/s41591-026-04324-7
- Record issued
- 2026-08-15
- Engine
- 7.39.0
- Exported
- 2026-09-22
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/9d345c0a-675b-491e-a3ca-c454c96e52c8 is authoritative.
How this rating was calculated
- IntegrityIntegrity concern ×3−1.5★
- CitationsCitations & links (capped) ×10−1★
- ClaimsEfficacy rests on an unvalidated surrogate endpoint−0.5★
- ClaimsTreatment effect not shown to be clinically meaningful−0.5★
- ReportingStudy design partially met−0.25★
- ReportingStatistical analysis partially met−0.25★
Citations & links are capped at −1★ combined, however many are flagged.
- Statistics were not checked: no recomputable values were found in this text — no test statistic reported with its degrees of freedom, no effect estimate printed with both a 95% CI and a p-value, and no percentage printed with both its count and its denominator.
- 01Efficacy rests on an unvalidated surrogate endpoint
The primary outcome is reduction in urinary levels of plastic-associated chemicals (PACs), which are biomarkers of exposure, not clinical outcomes. The paper does not demonstrate target engagement at the tested dose (no PK/PD data) nor cite validated evidence linking these urinary PAC levels to clinical outcomes. The claim that reducing PACs is beneficial is based on epidemiological associations, not established surrogate validation.
“The primary trial outcome was a reduction in urinary plastics-associated chemicals levels.”
- 02Treatment effect not shown to be clinically meaningful
The reported reductions in urinary PAC levels (e.g., 37.5% for MnBP, 53.5% for MBzP, 59.7% for BPA) are statistically significant but are not anchored to any clinical or biological meaningfulness. The paper does not provide a minimal clinically important difference or link these reductions to improved health outcomes. The effect sizes are presented as percentage changes in biomarkers without context of clinical benefit.
“urinary levels of mono-n-butyl phthalate, monobenzyl phthalate and bisphenol A by 37.5% (95% confidence interval (CI): −55.6, −12.0; P = 0.007), 53.5% (95% CI: −72.7, −20.6; P = 0.005) and 59.7% (95% CI: −82.5, −6.87; P = 0.033), respectively.”
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 paper is a well-conducted mixed-methods study (cohort + pilot RCT) with strong scientific premise, clear ethics, and transparent reporting. The main weaknesses are the lack of a formal power analysis, incomplete reporting of randomization/blinding details, and imprecise p-value reporting with no multiple-comparison correction.
Both reviewers classified the study as mixed (observational + interventional), which was adopted. The statistics verification component could not recompute any tests (total=0) due to limited reporting of test statistics and CIs, so mathematical correctness is not confirmed. The citation check flagged 10 references not found in registries, which are integrity concerns.
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
- lowinternal contradictionThe registration number in the Methods section has an extra digit compared to the Abstract.
“ACTRN126220012527070”
EthicsFind in source - lowinternal contradictionThe CI for Group 3 MnBP reduction is identical to Group 2's CI, which is suspicious.
“Group 3 (low-plastic PCPs only) decreased urinary MnBP by only 35.3% (95% CI: −55.6, −12.0; P = 0.013)”
ResultsFind in source
Overstated conclusions
2 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
7 major claims checked against the paper's own evidence: all adequately supported.
- supportedReviewer 1The RCT decreased urinary levels of MnBP, MBzP, and BPA.The reported effect sizes and CIs for the intervention groups support this claim.Evidence: Group 2 decreased MnBP by 37.5% (95% CI: −55.6, −12.0; P = 0.007), MBzP by 53.5% (95% CI: −72.7, −20.7; P = 0.005), and BPA by 59.7% (95% CI: −82.5, −6.88; P = 0.033).
decreased ... urinary levels of mono- n -butyl phthalate, monobenzyl phthalate and bisphenol A by 37.5% (95% confidence interval (CI): −55.6, −12.0; P = 0.007), 53.5% (95% CI: −72.7, −20.6; P = 0.005) and 59.7% (95% CI: −82.5, −6.87; P = 0.033), respectively.
Abstractreviewer’s wording - supportedReviewers 1, 2Highly processed, plastic-packaged and canned foods are important modifiable factors for urinary PAC levels.The cohort analyses show associations between these dietary factors and urinary PACs.Evidence: Each additional canned item was associated with 14.3% increase in urinary BPA (95% CI: 1.26, 29.1; P = 0.032).
“In the cohort study, highly processed, plastic-packaged and canned foods were important modifiable factors for urinary PAC metabolite levels.”
AbstractFind in source - supportedReviewer 1Negative associations between cardiometabolic biomarkers and higher urinary DEHP metabolites were observed.The reported associations support this claim, though the direction is unexpected.Evidence: Higher MEHP was associated with 23.2% lower hsCRP (95% CI: −36.6, −7.08; P = 0.007).
“we observed negative associations between cardiometabolic biomarkers and higher urinary di(2-ethylhexyl) phthalate metabolites.”
AbstractFind in source - supportedReviewers 1, 2Limiting food plastics touchpoints decreases select PACs in 7 days.The RCT results support this claim for specific PACs (MnBP, MBzP, BPA), though not for DEHP metabolites.Evidence: Groups 1, 2 and 4 combined decreased MnBP by 37.9% (95% CI: −53.0, −17.9; P < 0.001), MBzP by 44.5% (95% CI: −64.1, −14.3; P = 0.008), BPA by 51.6% (95% CI: −75.4, −4.62; P = 0.036).
“Despite constant plastic exposures, limiting food plastics touchpoints decreases select PACs in 7 days.”
AbstractFind in source - supportedReviewer 2The RCT reduced urinary levels of MnBP, MBzP, and BPA.The RCT results show significant decreases in these PACs in intervention groups compared to control, with effect sizes and CIs.Evidence: Group 2 decreased MnBP by 37.5% (95% CI: −55.6, −12.0; P = 0.007), MBzP by 53.5% (95% CI: −72.7, −20.7; P = 0.005), and BPA by 59.7% (95% CI: −82.5, −6.88; P = 0.033).
“Group 2 (low-plastic food and kitchenware) had greater decreases in urinary MnBP by 37.5% (95% CI: −55.6, −12.0; P = 0.007) and urinary MBzP by 53.5% (95% CI: −72.7, −20.7; P = 0.005) and decreased urinary BPA by 59.7% (95% CI: −82.5, −6.88; P = 0.033) compared with no intervention.”
ResultsFind in source - supportedReviewer 2Negative associations between cardiometabolic biomarkers and higher urinary DEHP metabolites.The cohort study found negative associations between DEHP metabolites and hsCRP and Lp(a), supporting the claim.Evidence: Higher MEHP associated with 23.2% lower hsCRP; higher MEOHP associated with 24.7% lower hsCRP and 30.5% lower Lp(a).
“Each one-unit-higher log-MEHP was associated with 23.2% lower high-sensitivity CRP (hsCRP) (95% CI: −36.6, −7.08; P = 0.007)”
ResultsFind in source - supportedReviewer 2The intervention maintained daily energy intake while decreasing plastic exposure.The RCT reported no change in energy intake in groups 1, 2, and 4, and decreased dietary plastic scores.Evidence: Changes in energy intake were not significant; Total Dietary Plastics Scores decreased in groups 1, 2, and 4.
“Replacing all foods and beverages with low-plastic alternatives did not change mean daily energy (kilojoule) intake in groups 1, 2 and 4 from baseline to post-trial”
ResultsFind in source
Premise concern: surrogate not validated for clinical benefit; effect size not shown to be clinically meaningful.
- INADEQUATESurrogate endpointThe primary outcome is reduction in urinary levels of plastic-associated chemicals (PACs), which are biomarkers of exposure, not clinical outcomes. The paper does not demonstrate target engagement at the tested dose (no PK/PD data) nor cite validated evidence linking these urinary PAC levels to clinical outcomes. The claim that reducing PACs is beneficial is based on epidemiological associations, not established surrogate validation.
“The primary trial outcome was a reduction in urinary plastics-associated chemicals levels.”
- INADEQUATEEffect sizeThe reported reductions in urinary PAC levels (e.g., 37.5% for MnBP, 53.5% for MBzP, 59.7% for BPA) are statistically significant but are not anchored to any clinical or biological meaningfulness. The paper does not provide a minimal clinically important difference or link these reductions to improved health outcomes. The effect sizes are presented as percentage changes in biomarkers without context of clinical benefit.
“urinary levels of mono-n-butyl phthalate, monobenzyl phthalate and bisphenol A by 37.5% (95% confidence interval (CI): −55.6, −12.0; P = 0.007), 53.5% (95% CI: −72.7, −20.6; P = 0.005) and 59.7% (95% CI: −82.5, −6.87; P = 0.033), respectively.”
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.
- Methods and results do not matchAssessed
3 integrity concerns flagged (0 high).
- lowmethod result mismatchThe paper states no formal multiple-comparison correction was applied, yet provides q-values for FDR in the methods; this is not a contradiction but could be clarified.
no formal correction for multiple comparisons was applied in the main body of the manuscript ... We provide the reader with q -values in the that control for the false discovery rates
Statistical analysisreviewer’s wording
Reporting gaps
2 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
- Study-design details incomplete (controls, blinding, power)Assessed
The introduction cites numerous epidemiological studies linking phthalates and bisphenols to adverse health outcomes, and identifies gaps in prior intervention research (small samples, short durations, single-food focus). The rationale for minimizing all plastic touchpoints is clearly linked to the study objectives. Limitations of prior work are explicitly acknowledged and addressed by the study design.
“numerous epidemiological studies have reported associations between exposure to these PACs and adverse health outcomes, including cardiovascular disease and metabolic syndrome”
“To address this gap, the present study aimed to minimize all plastic touchpoints during food production, handling, processing, packaging, storage and preparation, while also addressing non-dietary sources such as PCPs, in a healthy adult population.”
“numerous epidemiological studies have reported associations between exposure to these PACs and adverse health outcomes, including cardiovascular disease and metabolic syndrome”
“To address this gap, the present study aimed to minimize all plastic touchpoints during food production, handling, processing, packaging, storage and preparation, while also addressing non-dietary sources such as PCPs, in a healthy adult population.”
The RCT reports randomization (60 participants allocated to five groups) and blinding (participants and investigators), but the randomization method (e.g., random number generator, block design) is not described. A power analysis is not reported; the sample size of 12 per group is justified by a 'rule of thumb' reference. Inclusion/exclusion criteria are detailed. Outlier handling is not explicitly described, though the analysis population is defined. Controls are appropriate (no-intervention group). Independent replication is not applicable for a single pilot trial.
“Participants ( n = 60) were randomly allocated to one of five groups for the 7-day intervention”
“Sample size of 12 per group rule of thumb for a pilot study”
“Participants ( n = 60) were randomly allocated to one of five groups for the 7-day intervention”
Sex is reported for both studies (58% female in cohort, 60% in RCT). Age, BMI, and various health metrics are detailed in Table 1. Since both sexes are included, sex justification is not applicable. Demographics (ethnicity, sociodemographic) are presented in Extended Data Table 1. Species/strain and housing conditions are not applicable for human studies.
“211 adults (58% female, 43.1 ± 12.5 years) were recruited for the longitudinal PERTH cohort study”
“Female n (%) | 123 (100%) | 0 (0%) | 123 (58.3%) | 36 (100%) | 0 (0%) | 36 (60.0%)”
“Sociodemographic characteristics of the PERTH cohort study and RCT, by biological sex”
The paper states ethics approval from the University of Western Australia Human Research Ethics Committee with a protocol number (2021-ET001118). Informed consent is explicitly mentioned ('informed consent was obtained from all participants'). Regulatory compliance is stated ('All methods were carried out in accordance with the relevant guidelines and regulations').
“The PERTH Trial has ethics approval from the University of Western Australia Human Research Ethics Committee; 2021- ET001118”
“informed consent was obtained from all participants”
“All methods were carried out in accordance with the relevant guidelines and regulations”
“The PERTH Trial has ethics approval from the University of Western Australia Human Research Ethics Committee; 2021- ET001118”
“informed consent was obtained from all participants”
“All methods were carried out in accordance with the relevant guidelines and regulations”
The intervention components are described in detail (foods from producers minimizing plastic touchpoints, low-plastic kitchenware, low-plastic PCPs). The analytical laboratory and methods are mentioned. Statistical software (R version 4.3.1) is identified. Since this is a dietary/lifestyle intervention without drugs or bench reagents, most resource criteria are not applicable, but the intervention products are adequately described.
“Intervention groups received combinations of plastic-free kitchenware, low-plastic personal-care products and food sourced from more than 100 producers that minimized all plastic touchpoints from paddock to plate”
“All statistical analysis was performed using R (version 4.3.1, R Foundation for Statistical Computing)”
“Intervention groups received combinations of plastic-free kitchenware, low-plastic personal-care products and food sourced from more than 100 producers”
“All statistical analysis was performed using R (version 4.3.1, R Foundation for Statistical Computing)”
The paper names tests (e.g., Student's t-test, Wald t-statistics, Barnard's test) and reports effect sizes with 95% CIs. However, many p-values are reported as '<0.001' rather than exact values. The paper acknowledges that no formal multiple-comparison correction was applied in the main body, providing q-values in supplementary material. Assumptions for linear models are not explicitly verified. Data presentation includes forest plots and longitudinal plots with means and SDs.
“no formal correction for multiple comparisons was applied in the main body of the manuscript”
“decreased the urinary phthalate metabolites mono- n -butyl phthalate (MnBP) by 31.5% (95% CI: −51.3, −3.57; P = 0.030)”
“no formal correction for multiple comparisons was applied in the main body of the manuscript”
The data availability statement provides a concrete access route: de-identified participant data available on application to the corresponding author, with a defined timeframe (3 months to 3 years) and review process. This meets the standard for managed access to patient data. Repository deposit and accession numbers are not applicable for identifiable patient data. Code availability states no custom algorithms were used.
“No new or custom algorithms were used in the statistical analysis.”
“No new or custom algorithms were used in the statistical analysis.”
The trial is registered (ACTRN12622001252707). A CONSORT diagram is provided. Limitations are thoroughly discussed, including inability to verify PAC content in home-prepared food, lack of serum/adipose measurements, and underpowered subgroup analyses. Conclusions are appropriately cautious, acknowledging the exploratory nature. Funding and competing interests are disclosed.
“Australian and New Zealand Clinical Trials Registry: ACTRN12622001252707”
“Limitations of our study include the inability to verify the PAC content in food prepared in participants’ homes”
“Australian and New Zealand Clinical Trials Registry: ACTRN12622001252707”
“Limitations of our study include the inability to verify the PAC content in food prepared in participants’ homes”
Registered (2 IDs: ANZCTR). 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 82 references by DOI: 60 verified — 10 DOI unresolved, 12 no DOI (shown, not verified).
- UNRESOLVED10.1007/s11356-019-06576-6Association of exposure to phthalates with cardiometabolic risk factors in children and adolescents: a systematic review and meta-analysisCited DOI does not resolve to any Crossref record.
- UNRESOLVED10.1007/s11356-020-09044-8Human exposure to bisphenol A through dietary sources and development of diabetes mellitus: a cross-sectional study in Pakistani populationCited DOI does not resolve to any Crossref record.
- UNRESOLVED10.1080/10408398.2021.1985424Chemical contaminants in canned food and can-packaged food: a reviewCited DOI does not resolve to any Crossref record.
- UNRESOLVED10.1007/s11356-019-05934-8Canned food intake and urinary bisphenol A concentrations: a randomized crossover intervention studyCited DOI does not resolve to any Crossref record.
- UNRESOLVED10.1038/s41591-025-03165-0Health impacts of exposure to synthetic chemicals in foodCited DOI does not resolve to any Crossref record.
- UNRESOLVED10.1289/ehp13312Effects of behavioral, clinical, and policy interventions in reducing human exposure to bisphenols and phthalates: a scoping reviewCited DOI does not resolve to any Crossref record.
- UNRESOLVED10.1007/s10995-015-1707-1Reducing prenatal phthalate exposure through maternal dietary changes: results from a pilot studyCited DOI does not resolve to any Crossref record.
- UNRESOLVED10.1007/s11356-016-7616-9Occupational exposure to phthalates in relation to gender, consumer practices and body compositionCited DOI does not resolve to any Crossref record.
- UNRESOLVED10.1016/0041-008x(92)90372-6Phthalate ester effects on rat Sertoli cell function in vitro: effects of phthalate side chain and age of animalCited DOI does not resolve to any Crossref record.
- UNRESOLVED10.1007/s00204-003-0521-3Di(2-ethylhexyl)phthalate (DEHP) metabolites in human urine and serum after a single oral dose of deuterium-labelled DEHPCited DOI does not resolve to any Crossref record.
- NO DOIMapping the chemical complexity of plasticsNo DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
- NO DOI24th Australian Total Diet Study: Phase 2No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
- NO DOIAustralian Dietary GuidelinesNo DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
- NO DOICommission Regulation (EU) 2024/3190 of 19 December 2024 on the use of bisphenol A (BPA) and other bisphenols and bisphenol derivatives with harmonised classification for specific hazardous properties in certain materials and articles intended to come into contact with food, amending Regulation (EU) No 10/2011 and repealing Regulation (EU) 2018/213No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
- NO DOINational Health and Nutrition Examination Survey QuestionnaireNo DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
- NO DOINational Health and Nutrition Examination Survey (NHANES) DataNo DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
- NO DOINational Health and Nutrition Examination Survey, 2015–2016 dataNo DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
- NO DOIFoodworks.onlineNo DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
- NO DOIDefining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline—Third EditionNo DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
- NO DOISocio-Economic Indexes for Areas (SEIFA), AustraliaNo DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
- NO DOIConcise International Chemical Assessment Document 52: Diethyl PhthalateNo DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
- NO DOIUpdated Risk Assessment of Five PhthalatesNo DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
1 of 2 data/code links checked; 1 live; 1 not probed.
- datahttps://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=384643&isReview=trueUNVERIFIEDHTTP 403Liveness indeterminate — content not checked.
- datahttps://www.ncbi.nlm.nih.gov/nuccore/ET001118LIVEHTTP 200Resolves, but the content could not be matched to the paper.
Copyediting
5 minorWording, consistency and formatting errors that need correcting before submission.
No major wording or formatting errors. 5 minor suggestions below.
5 copyedit issues flagged: mostly consistency, typo, grammar.
- MINORtypoAbstract“mono- n -butyl phthalate”→ mono-n-butyl phthalateInconsistent spacing around hyphens.
- MINORconsistencyMethods, Ethics approval and registration“ACTRN126220012527070”→ ACTRN12622001252707Extra digit in registration number; inconsistent with Abstract.
- MINORgrammarDiscussion“The serves and decreased urinary BPS requires further investigation”→ The association between fruit and vegetable serves and decreased urinary BPS requires further investigationIncomplete sentence; likely missing subject.
- MINORclarityResults, Primary outcomes of the PERTH RCT“Group 3 (low-plastic PCPs only) decreased urinary MnBP by only 35.3% (95% CI: −55.6, −12.0; P = 0.013)”→ Verify CI; appears identical to Group 2's CI for MnBP.Potential copy-paste error; CI for Group 3 may be incorrect.
- MINORconsistencyMethods, Ethics approval“ACTRN126220012527070”→ ACTRN12622001252707Extra digit in registration number.
The published work is generally robust but has notable reporting gaps that an informed reader should weigh: the lack of a formal power analysis, unclear randomization/blinding details, and uncorrected multiple comparisons. The copyedit issues (e.g., inconsistent trial registration number, suspicious CI duplication) and the 10 unresolved references warrant correction or clarification.
- 1.HIGHreportingCorrect the trial registration number in the Methods (Ethics approval and registration) section from 'ACTRN126220012527070' to 'ACTRN12622001252707' to match the Abstract.The extra digit is an internal inconsistency that could undermine the registration's verifiability.
- 2.HIGHreportingVerify and correct the confidence interval for Group 3's MnBP reduction in the Results (Primary outcomes of the PERTH RCT); it appears identical to Group 2's CI, suggesting a copy-paste error.A duplicated CI is a potential data error that could mislead readers about the effect size.
- 3.HIGHstatisticsAdd a formal a priori power analysis or sample size justification with effect size, alpha, and power in the Methods (Statistical analysis) section.The current rule-of-thumb justification is insufficient for a definitive trial and is a common reviewer concern.
- 4.HIGHstatisticsReport exact p-values instead of thresholds (e.g., P < 0.001) in the Results and Abstract, or state that exact values are provided in supplementary tables.Threshold-only p-values are imprecise and prevent readers from assessing the strength of evidence.
- 5.HIGHstatisticsApply a formal multiple-comparison correction (e.g., FDR) to the primary RCT outcomes and report adjusted p-values or q-values in the Results.Without correction, the risk of false positives is increased given the number of outcomes tested.
- 6.HIGHstatisticsExplicitly state how outliers were handled in the statistical analysis, including any exclusions and reasons.Outlier handling is not reported, which is a transparency gap that could affect the results.
- 7.HIGHreportingClarify the blinding status of outcome assessors and data analysts in the Methods (Study design) section.The paper is inconsistent about whether the trial was blinded or open-label, which is important for assessing bias.
- 8.HIGHreportingAdd a statement on verification of statistical assumptions (normality, homoscedasticity) for the models used in the Methods (Statistical analysis) section.Assumption verification is not reported, which is a standard requirement for linear models.
- 9.HIGHreportingCorrect the incomplete sentence in the Discussion: 'The serves and decreased urinary BPS requires further investigation' to include the missing subject.The current sentence is grammatically incomplete and unclear.
- 10.HIGHreportingVerify the 10 references flagged as not found in any registry (e.g., 'Association of exposure to phthalates with cardiometabolic risk factors...' DOI 10.1007/s11356-019-06576-6) and correct or replace them if they are fabricated or erroneous.Unresolved references are a fabrication signal and must be checked for integrity.
- 11.MEDIUMreportingAdd a section on adverse events or safety monitoring in the RCT results.Safety monitoring is a standard component of RCT reporting and is currently missing.
- 12.MEDIUMdata codeProvide a data availability statement that includes a repository or platform for de-identified data (e.g., Vivli) rather than only 'on request'.A managed-access platform improves data accessibility and transparency.
- 13.MEDIUMreportingProvide the full statistical analysis plan as a supplementary document to enhance transparency.A pre-specified analysis plan helps prevent post-hoc analysis bias.
- 14.LOWcopyeditFix the inconsistent spacing in 'mono- n -butyl phthalate' in the Abstract to 'mono-n-butyl phthalate'.Minor typographical consistency improves readability.
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.
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