Kaimen Rigor reviewed

Rigor-Reviewed Manuscript

Accelerated continuous theta burst stimulation targeting left primary motor cortex for children with autism spectrum disorder: multicentre randomised sham controlled trial.

Name: Kaimen Rigor review — Accelerated continuous theta burst stimulation targeting left primary motor cortex for children with autism spectrum disorder: multicentre randomised sham controlled trial.
Item: Accelerated continuous theta burst stimulation targeting left primary motor cortex for children with autism spectrum disorder: multicentre randomised sham controlled trial.
Rating: 100
Author: Alpha1

Tan H, Ren T, Cao A, Fang S, Deng L, Hu B, Wang M, Cheng Y, Zhang X, Li Y, Zhang Y, Zhang L, Chen L, Zhou W, Zhang Q, Li J, Zhou X, Langley C, Luo Q, Zhang J, Sahakian BJ, Yuan TF, Li F

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Kaimen Rigor review — 2.75★ (Weak), 0 critical, 2 high issues for “Accelerated continuous theta burst stimulation targeting left primary motor cortex for children with autism spectrum disorder: multicentre randomised sham controlled trial.”

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Alpha1 Editorial

This rigor review was examined and confirmed by Alpha1 Editorial · August 15, 2026

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Accelerated continuous theta burst stimulation targeting left primary motor cortex for children with autism spectrum disorder: multicentre randomised sham controlled trial.

Tan H, Ren T, Cao A, Fang S, Deng L, Hu B, Wang M, Cheng Y, Zhang X, Li Y, Zhang Y, Zhang L, Chen L, Zhou W, Zhang Q, Li J, Zhou X, Langley C, Luo Q, Zhang J, Sahakian BJ, Yuan TF, Li F

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DOI

10.1136/bmj-2025-086295

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Kaimen Rigor reviewed

Rigor-Reviewed Manuscript

Accelerated continuous theta burst stimulation targeting left primary motor cortex for children with autism spectrum disorder: multicentre randomised sham controlled trial.

Tan H, Ren T, Cao A, Fang S, Deng L, Hu B, Wang M, Cheng Y, Zhang X, Li Y, Zhang Y, Zhang L, Chen L, Zhou W, Zhang Q, Li J, Zhou X, Langley C, Luo Q, Zhang J, Sahakian BJ, Yuan TF, Li F

Paper source

Accelerated continuous theta burst stimulation targeting left primary motor cortex for children with autism spectrum disorder: multicentre randomised sham controlled trial.

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Links back to this Kaimen Rigor review.

Alpha1 Editorial

This rigor review was examined and confirmed by Alpha1 Editorial · August 15, 2026

Kaimen Rigor review

Kaimen Rigor reviewed

2.75 / 5

Weak — serious problems found

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

IntegrityIntegrity concern ×3−1.5★
ClaimsEfficacy rests on an unvalidated surrogate endpoint−0.5★
CitationsUnresolved reference−0.25★

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

Biggest issues

01Efficacy rests on an unvalidated surrogate endpoint
highOverreachreviewer-assessedFull detail
The primary efficacy claim is based on the Social Responsiveness Scale, second edition (SRS-2), a caregiver-reported questionnaire that measures social communication impairment. This is a surrogate outcome, not a hard clinical endpoint. The paper does not provide evidence of target engagement at the tested dose (e.g., neurophysiological measures such as motor evoked potentials or functional imaging) nor does it cite validated evidence linking changes in SRS-2 scores to long-term clinical outcomes. Although the authors estimate a minimal clinically important difference (MCID) of 5.61 points, this is a post hoc anchor-based estimate from previous trials and not a validated link to clinical meaningfulness.
“The primary outcome was defined as the change in the total score of the Social Responsiveness Scale, second edition (SRS-2, school age version) from T0 to T1 and from T0 to T2.”
Find in source

Findings by category

101ArithmeticNumerical inconsistencies 202OverreachOverstated conclusions 03AuthenticityNone found 04DisclosureNone found 105AvailabilityBroken references and links 06Copyedit5 minor suggestions

This Kaimen Rigor review uses Kaimen Rigor reviewers trained on a curated corpus of high-fidelity and retracted papers, with expert supervision and curation. It can still make mistakes; verify each finding against the source before relying on it.

This is a well-conducted multicentre randomised sham-controlled trial with rigorous design, clear reporting, and adequate ethical and data-sharing practices. Minor reporting issues (threshold p-values, a typographical error in Table 3) do not affect the overall integrity of the study.

Both reviewers classified the study as interventional, and this was adopted. The evaluation covered the full text, with verification components checking citations, statistics, reproducibility, and preregistration. Non-applicable sub-criteria (e.g., animal housing, cell lines) were excluded from scoring.

Numerical inconsistencies

1 finding · worst low

Values that contradict each other or are impossible for the stated sample: recomputed p-values and test statistics, GRIM/GRIMMER checks on summary numbers, percentages against their own counts, totals against their parts, and estimates against their own confidence intervals.

Internal contradictions in the reported numbersAssessed

Recomputed 4 tests: 4 consistent, 0 inconsistent; 4 via agent-written checks.

Overstated conclusions

2 findings · worst high

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

Efficacy rests on an unvalidated surrogate endpointAssessed
Conclusions only partially backed by the presented evidenceAssessed

9 major claims checked against the paper's own evidence: 2 only partially supported (evidence backs part of the claim; gaps or caveats remain); the rest adequately supported.

Premise concern: surrogate not validated for clinical benefit.

Data authenticity concerns

None found

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

Checked — nothing surfaced.

Reporting gaps

None found

Required detail the manuscript never states — study design, biological variables, ethics approval and consent, key resources, statistical reporting, data and code availability, and overall transparency.

Checked — nothing surfaced.

Eight Dimensions8 pass

The introduction cites prior research on rTMS in ASD and acknowledges limitations of previous studies, including exclusion of young children and those with intellectual disability. The rationale links these gaps to the study's objectives and hypothesis. The paper also describes how the new protocol addresses prior limitations.

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

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

Evidence

“However, current empirical evidence remains limited and inconclusive.”

Introduction ¶2Find in source

“To address these challenges, we developed and evaluated a rTMS protocol adapted for young children with ASD and children with co-occurring intellectual disability.”

Introduction ¶3Find in source

“This design delivers a high cumulative dose of stimulation within a condensed time frame.”

Introduction ¶4Find in source

PASSReviewer 2· 90% conf

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

Evidence

“However, current empirical evidence remains limited and inconclusive.”

Introduction ¶2Find in source

“To address these challenges, we developed and evaluated a rTMS protocol adapted for young children with ASD and children with co-occurring intellectual disability.”

Introduction ¶3Find in source

“The trial included two key autism subpopulations that were frequently excluded from rTMS studies: children with intellectual disability and children of young age.”

LimitationsFind in source

Randomization method (block randomization, block length=4) and unit (participant) are stated. Blinding of participants and evaluators is described, with operators unmasked. Power analysis is reported with effect size, alpha, and power. Inclusion/exclusion criteria are pre-specified. Outlier handling is addressed through the modified intention-to-treat population and multiple imputation. Controls (sham) are described. Independent replication is not applicable for a single pivotal trial.

Sub-criteria

controlsADEQUATE

power analysisADEQUATE

blinding levelsADEQUATE

outlier handlingADEQUATE

randomization unitADEQUATE

inclusion exclusionADEQUATE

randomization methodADEQUATE

replicate distinctionN/A

independent replicationN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The trial design is rigorous with adequate randomization, blinding, power analysis, and inclusion/exclusion criteria.

Evidence

“using a block randomisation sequence (block length=4) generated by an independent coordinator in SPSS version 25.0”

MethodsFind in source

“Participants and evaluators were masked to interventions.”

MethodsFind in source

“Using a two sided α=0.025 to account for two primary outcomes, and assuming 80% power and 10% attrition, the required sample size was 186 participants.”

Statistical analysisFind in source

PASSReviewer 2· 95% conf

The trial design is rigorous with adequate randomization, blinding, power analysis, and inclusion/exclusion criteria.

Evidence

“using a block randomisation sequence (block length=4) generated by an independent coordinator in SPSS version 25.0”

MethodsFind in source

“Participants and evaluators were masked to interventions.”

MethodsFind in source

“Using a two sided α=0.025 to account for two primary outcomes, and assuming 80% power and 10% attrition, the required sample size was 186 participants.”

Statistical analysisFind in source

Sex is reported (167 boys and 33 girls). Age is reported (mean 6.5±1.6 years). Demographics include sex, age, and intellectual disability status. Species/strain and housing conditions are not applicable for a human trial. Sex justification is not applicable because both sexes are enrolled.

Sub-criteria

demographicsADEQUATE

sex reportedADEQUATE

sex justifiedN/A

age weight healthADEQUATE

housing conditionsN/A

species strain sourceN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Biological variables are adequately reported for a human trial, including sex, age, and demographics.

Evidence

“200 children aged 4-10 years with autism spectrum disorder (167 boys and 33 girls)”

AbstractFind in source

“50.5% of participants had co-occurring intellectual disability (full scale intelligence quotient <70)”

ResultsFind in source

PASSReviewer 2· 90% conf

Biological variables are adequately reported for a human trial, including sex, age, and health status.

Evidence

“200 eligible participants (mean age 6.5±1.6 years; 83.5% male)”

ResultsFind in source

“Eligible participants were children with ASD aged 4-10 years with a full scale intelligence quotient of 50 or higher.”

MethodsFind in source

The trial protocol was approved by named ethics committees of all participating sites, with a protocol number for one site. Written informed consent was obtained from legal guardians. Regulatory compliance with the Declaration of Helsinki and Good Clinical Practice is stated.

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

Ethical approvals and consent are adequately reported.

Evidence

“The trial protocol was approved by the ethics committees of Xinhua Hospital affiliated to Shanghai Jiao Tong University School of Medicine (XHEC-C-2023-043-4) and each participating site”

EthicsFind in source

“The study procedures and objectives were explained in person to the legal guardians of all participants, who provided written informed consent.”

EthicsFind in source

“The study was conducted in accordance with the Good Clinical Practice and the principles of the Declaration of Helsinki.”

EthicsFind in source

PASSReviewer 2· 95% conf

Ethical approvals and consent are adequately reported.

Evidence

“The trial protocol was approved by the ethics committees of Xinhua Hospital affiliated to Shanghai Jiao Tong University School of Medicine (XHEC-C-2023-043-4) and each participating site”

EthicsFind in source

“The study procedures and objectives were explained in person to the legal guardians of all participants, who provided written informed consent.”

EthicsFind in source

“The study was conducted in accordance with the Good Clinical Practice and the principles of the Declaration of Helsinki.”

EthicsFind in source

The investigational product (M-100 Ultimate, Shenzhen Yingchi Technology Co., China) is identified with manufacturer and model. Statistical software (R version 4.5.2) and SPSS version 25.0 are identified. No antibodies, cell lines, or organisms are used, so those criteria are not applicable.

Sub-criteria

mycoplasma testingN/A

reagents identifiedADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The investigational device is adequately identified, and software tools are named.

Evidence

“All sites used the same model of pulsed magnetic stimulation device (M-100 Ultimate, Shenzhen Yingchi Technology Co., China).”

MethodsFind in source

“All statistical analyses were performed using R version 4.5.2 (R Foundation for Statistical Computing, Vienna, Austria).”

Statistical analysisFind in source

PASSReviewer 2· 90% conf

The investigational device and software are adequately identified.

Evidence

“All sites used the same model of pulsed magnetic stimulation device (M-100 Ultimate, Shenzhen Yingchi Technology Co., China).”

MethodsFind in source

“All statistical analyses were performed using R version 4.5.2 (R Foundation for Statistical Computing, Vienna, Austria).”

Statistical analysisFind in source

Statistical tests are named (linear regression, ordinal logistic regression). Assumptions are handled by design (mixed models, multiple imputation). Exact p-values are reported for primary outcomes. Effect sizes with CIs are reported. Software is identified. Data presentation includes per-group n and CIs. Mathematical plausibility is not applicable for large-N continuous outcomes.

Sub-criteria

tests namedADEQUATE

exact p valuesADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedADEQUATE

assumptions verifiedADEQUATE

mathematical plausibilityN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Statistical methods are well described, with named tests, effect sizes with CIs, and appropriate data presentation.

Evidence

“the group differences in changes were assessed using linear regression”

Statistical analysisFind in source

paraphrase[Abstract, Results]

“P<0.001”

“−6.25, 95% confidence interval −8.69 to −3.81; Cohen’s d −0.92”

AbstractFind in source

PASSReviewer 2· 90% conf

Statistical analysis is rigorous with named tests, effect sizes with CIs, and appropriate handling of missing data.

Evidence

“the group differences in changes were assessed using linear regression”

Statistical analysisFind in source

“mean difference in SRS-2 scores of −6.25 (95% confidence interval (CI) −8.69 to −3.81; Cohen’s d −0.92; P<0.001)”

ResultsFind in source

paraphrase[Results, Primary efficacy outcome]

“P<0.001”

A data availability statement is present, naming a public repository (OSF) with a URL. Code is stated to be in the supplementary appendix. Repository deposit is applicable and adequate. Accession numbers are not applicable for this type of data. Code sharing is adequate as the code is in the appendix.

Sub-criteria

code sharingADEQUATE

accession numbersN/A

repository depositADEQUATE

data availability statementADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

Data and code availability are adequately reported with a public repository and code in the appendix.

Evidence

“The data underlying the findings in this paper are openly and publicly available and can be found at: https://osf.io/tg9me/overview”

Data availabilityFind in source

“The code used to analyse the data in the paper can be found in the supplementary appendix.”

Data availabilityFind in source

PASSReviewer 2· 95% conf

Data and code availability are adequately reported with a public repository and code in the appendix.

Evidence

“The data underlying the findings in this paper are openly and publicly available and can be found at: https://osf.io/tg9me/overview”

Data availabilityFind in source

“The code used to analyse the data in the paper can be found in the supplementary appendix.”

Data availabilityFind in source

The trial is registered (NCT05927792). CONSORT guidelines are followed. All outcomes are reported, including negative results. Limitations are discussed. Conclusions are proportional. Funding and conflicts of interest are disclosed.

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineADEQUATE

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Reporting is transparent with trial registration, CONSORT adherence, limitations, and funding/COI statements.

Evidence

“ClinicalTrials.gov NCT05927792”

AbstractFind in source

“This study followed the CONSORT (consolidated standards of reporting trials) guidelines”

MethodsFind in source

“Several limitations warrant consideration when interpreting the results.”

LimitationsFind in source

PASSReviewer 2· 95% conf

Reporting is transparent with trial registration, CONSORT adherence, and discussion of limitations.

Evidence

“Trial registration ClinicalTrials.gov NCT05927792”

AbstractFind in source

“This study followed the CONSORT (consolidated standards of reporting trials) guidelines”

MethodsFind in source

“Several limitations warrant consideration when interpreting the results.”

LimitationsFind in source

Registered (1 ID: ClinicalTrials.gov). Reporting guideline cited: CONSORT.

Broken references and links

1 finding · worst low

References checked against Crossref, OpenAlex and Retraction Watch for retractions and resolvability, plus declared data and code links probed for whether they resolve to content matching the paper.

References not resolvable to a published paperRecomputed

Checked 70 references by DOI: 64 verified — 1 DOI unresolved, 5 no DOI (shown, not verified).

1 data/code link checked; 1 live.

Copyediting

5 minor

Wording, 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, clarity.

Kaimen Rigor Action ItemsFinal pass before journal submission

The published work is robust and well-reported. An informed reader should weigh the minor reporting inconsistencies (threshold p-values, Table 3 typo) and the unresolved reference, but these do not undermine the main conclusions. No erratum is urgently required, though correcting the Table 3 percentage and clarifying the abstract would improve clarity.

1.
HIGHcopyedit
Correct the tinnitus row in Table 3: change the sham group percentage from '0' to '2.0%' (2/99) to match the count.
The current entry '2 (0)' is internally inconsistent and could mislead readers about adverse event rates.
2.
HIGHreporting
Verify or correct the reference 'Research priorities' (DOI 10.1016/s2215-0366(24) which could not be found in any registry; if it is a real paper, provide the complete DOI and confirm it exists.
An unresolved reference is a potential fabrication signal and must be resolved before the paper is relied upon.
3.
MEDIUMstatistics
Report exact p-values instead of thresholds (e.g., P<0.001) for primary and secondary outcomes in the abstract and results.
Threshold p-values are less informative and were flagged by both reviewers and the copyedit pass as a clarity issue.
4.
MEDIUMreporting
Clarify in the abstract that the language improvements were observed on the MAIN measure only, not all language measures.
The current wording could be misinterpreted as all secondary outcomes being significant, which overstates the findings.
5.
MEDIUMdata code
Provide the statistical analysis code in a version-controlled public repository (e.g., GitHub) with a DOI, in addition to the supplementary appendix.
This would enhance reproducibility and is a common expectation for data-driven papers.
6.
MEDIUMreporting
Add a more detailed description of the multiple imputation procedure (variables used, number of imputations) in the main text.
Currently only in the supplementary, this detail is important for assessing the robustness of the primary analysis.
7.
MEDIUMreporting
Report the results of the masking integrity assessment in the main text rather than only in the supplementary.
Blinding integrity is a key quality indicator for sham-controlled trials and should be transparently reported.
8.
MEDIUMreporting
Discuss the potential impact of the baseline SRS-2 imbalance on the primary outcome in more detail, even though sensitivity analyses were performed.
This addresses a potential confound that readers may question.
9.
MEDIUMreporting
Report the MCID estimation method in the main text, as it is currently only in the supplementary methods.
The minimal clinically important difference is central to interpreting the clinical significance of the results.
10.
LOWdata code
Remove or clarify the DOI (10.1177/1362361320967790) in the data availability statement, as it appears unrelated to the OSF link.
The unrelated DOI could confuse readers about the data location.
11.
LOWreporting
Add a statement about the availability of the study protocol and statistical analysis plan in a public repository.
This would further enhance transparency and adherence to open science practices.

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Accelerated continuous theta burst stimulation targeting left primary motor cortex for children with autism spectrum disorder: multicentre randomised sham controlled trial.

Tan H, Ren T, Cao A, Fang S, Deng L, Hu B, Wang M, Cheng Y, Zhang X, Li Y, Zhang Y, Zhang L, Chen L, Zhou W, Zhang Q, Li J, Zhou X, Langley C, Luo Q, Zhang J, Sahakian BJ, Yuan TF, Li F

Read full text (PMC)

DOI

10.1136/bmj-2025-086295

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Record fingerprint

b08aff7d57e2c4333c73393bc1728f2354da467ecef349397e4acb00b6ca0dda

Verify via API

Issued Aug 15, 2026Engine 7.39.0

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

Kaimen Rigor review

Kaimen Rigor reviewed

2.75 / 5

Weak — serious problems found

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

IntegrityIntegrity concern ×3−1.5★
ClaimsEfficacy rests on an unvalidated surrogate endpoint−0.5★
CitationsUnresolved reference−0.25★

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

Biggest issues

01Efficacy rests on an unvalidated surrogate endpoint
highOverreachreviewer-assessedFull detail
The primary efficacy claim is based on the Social Responsiveness Scale, second edition (SRS-2), a caregiver-reported questionnaire that measures social communication impairment. This is a surrogate outcome, not a hard clinical endpoint. The paper does not provide evidence of target engagement at the tested dose (e.g., neurophysiological measures such as motor evoked potentials or functional imaging) nor does it cite validated evidence linking changes in SRS-2 scores to long-term clinical outcomes. Although the authors estimate a minimal clinically important difference (MCID) of 5.61 points, this is a post hoc anchor-based estimate from previous trials and not a validated link to clinical meaningfulness.
“The primary outcome was defined as the change in the total score of the Social Responsiveness Scale, second edition (SRS-2, school age version) from T0 to T1 and from T0 to T2.”
Find in source

Findings by category

101ArithmeticNumerical inconsistencies 202OverreachOverstated conclusions 03AuthenticityNone found 04DisclosureNone found 105AvailabilityBroken references and links 06Copyedit5 minor suggestions

Numerical inconsistencies

1 finding · worst low

Internal contradictions in the reported numbersAssessed

Recomputed 4 tests: 4 consistent, 0 inconsistent; 4 via agent-written checks.

Overstated conclusions

2 findings · worst high

Efficacy rests on an unvalidated surrogate endpointAssessed
Conclusions only partially backed by the presented evidenceAssessed

9 major claims checked against the paper's own evidence: 2 only partially supported (evidence backs part of the claim; gaps or caveats remain); the rest adequately supported.

Premise concern: surrogate not validated for clinical benefit.

Data authenticity concerns

None found

Checked — nothing surfaced.

Reporting gaps

None found

Checked — nothing surfaced.

Eight Dimensions8 pass

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

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

Evidence

“However, current empirical evidence remains limited and inconclusive.”

Introduction ¶2Find in source

“To address these challenges, we developed and evaluated a rTMS protocol adapted for young children with ASD and children with co-occurring intellectual disability.”

Introduction ¶3Find in source

“This design delivers a high cumulative dose of stimulation within a condensed time frame.”

Introduction ¶4Find in source

PASSReviewer 2· 90% conf

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

Evidence

“However, current empirical evidence remains limited and inconclusive.”

Introduction ¶2Find in source

“To address these challenges, we developed and evaluated a rTMS protocol adapted for young children with ASD and children with co-occurring intellectual disability.”

Introduction ¶3Find in source

“The trial included two key autism subpopulations that were frequently excluded from rTMS studies: children with intellectual disability and children of young age.”

LimitationsFind in source

Sub-criteria

controlsADEQUATE

power analysisADEQUATE

blinding levelsADEQUATE

outlier handlingADEQUATE

randomization unitADEQUATE

inclusion exclusionADEQUATE

randomization methodADEQUATE

replicate distinctionN/A

independent replicationN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The trial design is rigorous with adequate randomization, blinding, power analysis, and inclusion/exclusion criteria.

Evidence

“using a block randomisation sequence (block length=4) generated by an independent coordinator in SPSS version 25.0”

MethodsFind in source

“Participants and evaluators were masked to interventions.”

MethodsFind in source

“Using a two sided α=0.025 to account for two primary outcomes, and assuming 80% power and 10% attrition, the required sample size was 186 participants.”

Statistical analysisFind in source

PASSReviewer 2· 95% conf

The trial design is rigorous with adequate randomization, blinding, power analysis, and inclusion/exclusion criteria.

Evidence

“using a block randomisation sequence (block length=4) generated by an independent coordinator in SPSS version 25.0”

MethodsFind in source

“Participants and evaluators were masked to interventions.”

MethodsFind in source

“Using a two sided α=0.025 to account for two primary outcomes, and assuming 80% power and 10% attrition, the required sample size was 186 participants.”

Statistical analysisFind in source

Sub-criteria

demographicsADEQUATE

sex reportedADEQUATE

sex justifiedN/A

age weight healthADEQUATE

housing conditionsN/A

species strain sourceN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Biological variables are adequately reported for a human trial, including sex, age, and demographics.

Evidence

“200 children aged 4-10 years with autism spectrum disorder (167 boys and 33 girls)”

AbstractFind in source

“50.5% of participants had co-occurring intellectual disability (full scale intelligence quotient <70)”

ResultsFind in source

PASSReviewer 2· 90% conf

Biological variables are adequately reported for a human trial, including sex, age, and health status.

Evidence

“200 eligible participants (mean age 6.5±1.6 years; 83.5% male)”

ResultsFind in source

“Eligible participants were children with ASD aged 4-10 years with a full scale intelligence quotient of 50 or higher.”

MethodsFind in source

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

Ethical approvals and consent are adequately reported.

Evidence

“The trial protocol was approved by the ethics committees of Xinhua Hospital affiliated to Shanghai Jiao Tong University School of Medicine (XHEC-C-2023-043-4) and each participating site”

EthicsFind in source

“The study procedures and objectives were explained in person to the legal guardians of all participants, who provided written informed consent.”

EthicsFind in source

“The study was conducted in accordance with the Good Clinical Practice and the principles of the Declaration of Helsinki.”

EthicsFind in source

PASSReviewer 2· 95% conf

Ethical approvals and consent are adequately reported.

Evidence

“The trial protocol was approved by the ethics committees of Xinhua Hospital affiliated to Shanghai Jiao Tong University School of Medicine (XHEC-C-2023-043-4) and each participating site”

EthicsFind in source

“The study procedures and objectives were explained in person to the legal guardians of all participants, who provided written informed consent.”

EthicsFind in source

“The study was conducted in accordance with the Good Clinical Practice and the principles of the Declaration of Helsinki.”

EthicsFind in source

Sub-criteria

mycoplasma testingN/A

reagents identifiedADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The investigational device is adequately identified, and software tools are named.

Evidence

“All sites used the same model of pulsed magnetic stimulation device (M-100 Ultimate, Shenzhen Yingchi Technology Co., China).”

MethodsFind in source

“All statistical analyses were performed using R version 4.5.2 (R Foundation for Statistical Computing, Vienna, Austria).”

Statistical analysisFind in source

PASSReviewer 2· 90% conf

The investigational device and software are adequately identified.

Evidence

“All sites used the same model of pulsed magnetic stimulation device (M-100 Ultimate, Shenzhen Yingchi Technology Co., China).”

MethodsFind in source

“All statistical analyses were performed using R version 4.5.2 (R Foundation for Statistical Computing, Vienna, Austria).”

Statistical analysisFind in source

Sub-criteria

tests namedADEQUATE

exact p valuesADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedADEQUATE

assumptions verifiedADEQUATE

mathematical plausibilityN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Statistical methods are well described, with named tests, effect sizes with CIs, and appropriate data presentation.

Evidence

“the group differences in changes were assessed using linear regression”

Statistical analysisFind in source

paraphrase[Abstract, Results]

“P<0.001”

“−6.25, 95% confidence interval −8.69 to −3.81; Cohen’s d −0.92”

AbstractFind in source

PASSReviewer 2· 90% conf

Statistical analysis is rigorous with named tests, effect sizes with CIs, and appropriate handling of missing data.

Evidence

“the group differences in changes were assessed using linear regression”

Statistical analysisFind in source

“mean difference in SRS-2 scores of −6.25 (95% confidence interval (CI) −8.69 to −3.81; Cohen’s d −0.92; P<0.001)”

ResultsFind in source

paraphrase[Results, Primary efficacy outcome]

“P<0.001”

Sub-criteria

code sharingADEQUATE

accession numbersN/A

repository depositADEQUATE

data availability statementADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

Data and code availability are adequately reported with a public repository and code in the appendix.

Evidence

“The data underlying the findings in this paper are openly and publicly available and can be found at: https://osf.io/tg9me/overview”

Data availabilityFind in source

“The code used to analyse the data in the paper can be found in the supplementary appendix.”

Data availabilityFind in source

PASSReviewer 2· 95% conf

Data and code availability are adequately reported with a public repository and code in the appendix.

Evidence

“The data underlying the findings in this paper are openly and publicly available and can be found at: https://osf.io/tg9me/overview”

Data availabilityFind in source

“The code used to analyse the data in the paper can be found in the supplementary appendix.”

Data availabilityFind in source

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineADEQUATE

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Reporting is transparent with trial registration, CONSORT adherence, limitations, and funding/COI statements.

Evidence

“ClinicalTrials.gov NCT05927792”

AbstractFind in source

“This study followed the CONSORT (consolidated standards of reporting trials) guidelines”

MethodsFind in source

“Several limitations warrant consideration when interpreting the results.”

LimitationsFind in source

PASSReviewer 2· 95% conf

Reporting is transparent with trial registration, CONSORT adherence, and discussion of limitations.

Evidence

“Trial registration ClinicalTrials.gov NCT05927792”

AbstractFind in source

“This study followed the CONSORT (consolidated standards of reporting trials) guidelines”

MethodsFind in source

“Several limitations warrant consideration when interpreting the results.”

LimitationsFind in source

Registered (1 ID: ClinicalTrials.gov). Reporting guideline cited: CONSORT.

Broken references and links

1 finding · worst low

References checked against Crossref, OpenAlex and Retraction Watch for retractions and resolvability, plus declared data and code links probed for whether they resolve to content matching the paper.

References not resolvable to a published paperRecomputed

Checked 70 references by DOI: 64 verified — 1 DOI unresolved, 5 no DOI (shown, not verified).

1 data/code link checked; 1 live.

Copyediting

5 minor

Wording, 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, clarity.

Kaimen Rigor Action ItemsFinal pass before journal submission

1.
HIGHcopyedit
Correct the tinnitus row in Table 3: change the sham group percentage from '0' to '2.0%' (2/99) to match the count.
The current entry '2 (0)' is internally inconsistent and could mislead readers about adverse event rates.
2.
HIGHreporting
Verify or correct the reference 'Research priorities' (DOI 10.1016/s2215-0366(24) which could not be found in any registry; if it is a real paper, provide the complete DOI and confirm it exists.
An unresolved reference is a potential fabrication signal and must be resolved before the paper is relied upon.
3.
MEDIUMstatistics
Report exact p-values instead of thresholds (e.g., P<0.001) for primary and secondary outcomes in the abstract and results.
Threshold p-values are less informative and were flagged by both reviewers and the copyedit pass as a clarity issue.
4.
MEDIUMreporting
Clarify in the abstract that the language improvements were observed on the MAIN measure only, not all language measures.
The current wording could be misinterpreted as all secondary outcomes being significant, which overstates the findings.
5.
MEDIUMdata code
Provide the statistical analysis code in a version-controlled public repository (e.g., GitHub) with a DOI, in addition to the supplementary appendix.
This would enhance reproducibility and is a common expectation for data-driven papers.
6.
MEDIUMreporting
Add a more detailed description of the multiple imputation procedure (variables used, number of imputations) in the main text.
Currently only in the supplementary, this detail is important for assessing the robustness of the primary analysis.
7.
MEDIUMreporting
Report the results of the masking integrity assessment in the main text rather than only in the supplementary.
Blinding integrity is a key quality indicator for sham-controlled trials and should be transparently reported.
8.
MEDIUMreporting
Discuss the potential impact of the baseline SRS-2 imbalance on the primary outcome in more detail, even though sensitivity analyses were performed.
This addresses a potential confound that readers may question.
9.
MEDIUMreporting
Report the MCID estimation method in the main text, as it is currently only in the supplementary methods.
The minimal clinically important difference is central to interpreting the clinical significance of the results.
10.
LOWdata code
Remove or clarify the DOI (10.1177/1362361320967790) in the data availability statement, as it appears unrelated to the OSF link.
The unrelated DOI could confuse readers about the data location.
11.
LOWreporting
Add a statement about the availability of the study protocol and statistical analysis plan in a public repository.
This would further enhance transparency and adherence to open science practices.

Full text (56,997 chars)Analyzed: Aug 15, 2026