Kaimen Rigor reviewed

Rigor-Reviewed Manuscript

Sonolysis during carotid endarterectomy: randomised controlled trial.

Name: Kaimen Rigor review — Sonolysis during carotid endarterectomy: randomised controlled trial.
Item: Sonolysis during carotid endarterectomy: randomised controlled trial.
Rating: 100
Author: Alpha1

Školoudík D, Hrbáč T, Kovář M, Beneš V 3rd, Fiedler J, Branca M, Rossel JB, Netuka D, SONOBIRDIE Trial Investigators

Paper source

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Kaimen Rigor review — 3★ (Adequate), 0 critical, 3 high issues for “Sonolysis during carotid endarterectomy: randomised 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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Sonolysis during carotid endarterectomy: randomised controlled trial.

Školoudík D, Hrbáč T, Kovář M, Beneš V 3rd, Fiedler J, Branca M, Rossel JB, Netuka D, SONOBIRDIE Trial Investigators

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DOI

10.1136/bmj-2024-082750

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7f6b448cfca801d6f711182c95d4cd7b002902ec168c9f6465ccffccca7a80b0

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Issued Aug 15, 2026Engine 7.39.0

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Kaimen Rigor reviewed

Rigor-Reviewed Manuscript

Sonolysis during carotid endarterectomy: randomised controlled trial.

Školoudík D, Hrbáč T, Kovář M, Beneš V 3rd, Fiedler J, Branca M, Rossel JB, Netuka D, SONOBIRDIE Trial Investigators

Paper source

Sonolysis during carotid endarterectomy: randomised controlled trial.

Read full text (PMC)

Embed this Rigor badge

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

3 / 5

Adequate — real issues to address

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

IntegrityIntegrity concern ×3−1.5★
ClaimsOverstated claim−0.5★

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

Not verified in this report

The numeric-impossibility checks (GRIM/GRIMMER/DEBIT/SPRITE) did not run: 6 reported means were read, and their group size is not stated where the values are printed (this source has no machine-readable table structure). These checks need the count the mean was averaged over, so none was performed.

Biggest issues

01Conclusion reaches beyond the evidence
mediumOverreachreviewer-assessedFull detail
Sonolysis should be used to reduce periprocedural cerebrovascular events during carotid endarterectomy.
“The results of the SONOBIRDIE trial suggest that sonolysis should be used to reduce the risk of periprocedural cerebrovascular events during carotid endarterectomy in all patients with sufficient temporal bone window for transcranial Doppler.”
DiscussionFind in source

Findings by category

101ArithmeticNumerical inconsistencies 102OverreachOverstated conclusions 103AuthenticityData authenticity concerns 04DisclosureNone found 05AvailabilityNone found 06Copyedit6 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, rigorously reported phase 3 randomised sham-controlled trial. The paper demonstrates strong methodology across all eight dimensions, with clear reporting of design, ethics, data availability, and statistical methods. Minor reporting gaps (e.g., software version, explicit CONSORT statement) and a few copyedit issues do not undermine the overall integrity.

Both reviewers classified the study as interventional, and this was adopted. The evaluation covered all eight dimensions; non-applicable sub-criteria (e.g., animal housing, cell line authentication) were excluded. The statistics verification covered only a subset of tests (2 tests), so the overall statistical soundness is not fully confirmed. The claim audit flagged one claim as 'overstated'.

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 2 tests: 2 consistent, 0 inconsistent; 2 via agent-written checks.

Overstated conclusions

1 finding · worst medium

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.

Conclusions overstated beyond the evidenceAssessed

5 major claims checked against the paper's own evidence: 1 not fully backed by the presented evidence (unsupported or overstated).

Efficacy claim is anchored to an adequate endpoint and a meaningful effect.

Data authenticity concerns

1 finding · worst low

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.

Other integrity concernAssessed

3 integrity concerns flagged (0 high).

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 in vitro, animal, and pilot studies supporting the potential of sonolysis, and acknowledges the unclear mechanism. The hypothesis follows logically from the cited evidence. Limitations of prior research are implicitly addressed by the design of a large RCT.

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 with extensive prior work and a logical hypothesis.

Evidence

“Since the 1970s, in vitro and animal model studies have shown acceleration of thrombus dissolution by use of an ultrasound beam.”

Introduction ¶1Find in source

“Therefore, we hypothesised that activation of the fibrinolytic system and a direct mechanical effect on flowing thrombi in intracranial arteries by use of sonolysis during carotid endarterectomy could reduce the risk of cerebrovascular events, such as ischaemic stroke, transient ischaemic attack, and silent brain infarction.”

Introduction ¶3Find in source

“The exact mechanism of the therapeutic effect of sonolysis—that is, continuous pulsed wave Doppler insonation of an artery for prevention and treatment of brain ischaemia—remains unclear, although it has been studied for more than 50 years.”

Discussion ¶2Find in source

PASSReviewer 2· 90% conf

The paper establishes a clear scientific premise with extensive prior work and a logical rationale for the hypothesis.

Evidence

“Since the 1970s, in vitro and animal model studies have shown acceleration of thrombus dissolution by use of an ultrasound beam.”

Introduction ¶1Find in source

paraphrase[Introduction, paragraph 4]

paraphrase[Introduction, paragraph 3]

“Pilot studies have shown a potential positive effect of sonolysis on reduction of the risk of stroke or brain infarction during interventions.”

Randomisation was computer-generated with 1:1 allocation via an independent online system. Blinding was double-blind, with only the sonographer unblinded. A priori power analysis was performed for both the main trial and substudy. Inclusion/exclusion criteria were pre-specified. The analysis population (ITT and per-protocol) was defined, and missing data handling was described. The sham procedure served as a control.

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· 95% conf

The trial design is rigorous with proper randomisation, blinding, sample size calculation, and pre-specified criteria.

Evidence

“Consecutive patients were assigned to the sonolysis group or the control group by computer generated one-to-one randomisation using an independent online randomisation system.”

MethodsFind in source

“Only the sonographer was not blinded to the application of sonolysis or sham procedure.”

MethodsFind in source

“A χ 2 test indicated that 1342 patients (671 per group) were needed to detect such a difference with a two sided α level of 0.05 and a power of 80%.”

Statistical analysisFind in source

PASSReviewer 2· 95% conf

The trial design is rigorous with adequate randomisation, blinding, sample size calculation, and pre-specified criteria.

Evidence

“Consecutive patients were assigned to the sonolysis group or the control group by computer generated one-to-one randomisation using an independent online randomisation system.”

MethodsFind in source

“Only the sonographer was not blinded to the application of sonolysis or sham procedure.”

MethodsFind in source

“A χ 2 test indicated that 1342 patients (671 per group) were needed to detect such a difference with a two sided α level of 0.05 and a power of 80%.”

Statistical analysisFind in source

The paper reports sex (31% female), age (mean 67.9 years), and health status (comorbidities, medication use). Demographics are detailed in Table 1. Since both sexes are enrolled, sex justification is not applicable. Species/strain and housing conditions are not applicable for a human trial.

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

Demographic and clinical characteristics are well reported, including sex, age, and health status.

Evidence

“1004 patients (mean age 68 years; 312 (31%) female) were enrolled”

AbstractFind in source

paraphrase[Table 1]

“Age, years: Mean (SD) | 68 (8.0) | 68 (7.7)”

PASSReviewer 2· 90% conf

Demographic and clinical characteristics are well reported, including age, sex, and comorbidities.

Evidence

“1004 patients (mean age 68 years; 312 (31%) female) were enrolled”

Table 1Find in source

“Arterial hypertension | 432 (85) | 448 (90)”

Table 1Find in source

The protocol was approved by a named ethics committee (multicentre ethics committee of Vítkovice Hospital) and local IRBs. Written informed consent was obtained from all patients. Regulatory compliance is implied by adherence to standard trial conduct.

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 approval and informed consent are clearly documented.

Evidence

“The protocol was approved by the multicentre ethics committee of Vítkovice Hospital (2 June 2015) and local institutional review boards of the participating centres.”

EthicsFind in source

“All patients provided written informed consent.”

EthicsFind in source

PASSReviewer 2· 95% conf

Ethical approval and informed consent are clearly documented.

Evidence

“The protocol was approved by the multicentre ethics committee of Vítkovice Hospital (2 June 2015) and local institutional review boards of the participating centres.”

EthicsFind in source

“All patients provided written informed consent.”

EthicsFind in source

The investigational device is described in detail (2 MHz transcranial Doppler probe, ultrasound machines listed in supplementary table B). Statistical software (R, version not specified) is mentioned in the methods. No antibodies, cell lines, or other biological reagents are used.

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· 85% conf

The investigational device (ultrasound machine and probe) is adequately identified, and statistical software is named.

Evidence

“Sonolysis in the SONOBIRDIE trial was performed using a standard ultrasound machine and 2 MHz transcranial Doppler probe.”

MethodsFind in source

paraphrase[Methods, Statistical analysis]

“The statistical analysis section mentions the use of R software (version not specified).”

PASSReviewer 2· 85% conf

The investigational device (ultrasound machine and probe) is adequately identified, and statistical software is mentioned.

Evidence

“Sonolysis in the SONOBIRDIE trial was performed using a standard ultrasound machine and 2 MHz transcranial Doppler probe.”

MethodsFind in source

“The code used to analyse the data in the paper can be found in the supplemental files.”

Data availabilityFind in source

All statistical tests are named (χ², log-rank, cumulative incidence, etc.). Exact p-values are reported (e.g., P<0.001, P=0.004). Effect sizes with 95% CIs are provided. Statistical software (R) is identified. Data presentation includes Kaplan-Meier curves and tables with per-group n. Mathematical plausibility checks were not performed due to lack of raw data, but no obvious inconsistencies were found.

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 comprehensive, with named tests, exact p-values, effect sizes with CIs, and appropriate data presentation.

Evidence

paraphrase[Abstract]

“P<0.001”

“risk difference −5.5%, 95% confidence interval (CI) −8.3% to −2.8%”

AbstractFind in source

paraphrase[Methods, Statistical analysis]

“The statistical analysis section mentions the use of R software (version not specified).”

PASSReviewer 2· 90% conf

Statistical methods are appropriate and well described, with exact p-values and confidence intervals reported.

Evidence

“We used a χ 2 test to compare the groups.”

Statistical analysisFind in source

paraphrase[Abstract and Results]

“P<0.001”

“risk difference −5.5%, 95% confidence interval (CI) −8.3% to −2.8%”

AbstractFind in source

The data availability statement provides a direct link to a public repository (Mendeley Data) with a DOI. The code is stated to be in supplemental files. This meets the criteria for adequate data and code sharing.

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 are openly available with a persistent identifier.

Evidence

“The data underlying the findings in this paper are openly and publicly available and can be found here: https://data.mendeley.com/datasets/gkzrhyc6tj/1”

Data availabilityFind in source

“The code used to analyse the data in the paper can be found in the supplemental files.”

Data availabilityFind in source

PASSReviewer 2· 95% conf

Data and code are openly available with a persistent identifier.

Evidence

“The data underlying the findings in this paper are openly and publicly available and can be found here: https://data.mendeley.com/datasets/gkzrhyc6tj/1”

Data availabilityFind in source

“The code used to analyse the data in the paper can be found in the supplemental files.”

Data availabilityFind in source

The trial is registered at ClinicalTrials.gov (NCT02398734). The paper follows CONSORT guidelines (flowchart provided). All outcomes are reported, including negative results. Limitations are discussed in the Discussion. Conclusions are proportional to the evidence. Funding sources and competing interests are declared.

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

The trial is registered, reporting guidelines are followed, limitations are discussed, and funding/COI are disclosed.

Evidence

“Trial registration Clinicaltrials.gov NCT02398734”

AbstractFind in source

“One limitation of the study was that no study specific ultrasound device was used and only standard ultrasound (transcranial Doppler) machines were used, which did not allow blinding for the sonographer.”

LimitationsFind in source

“The study was partially founded by the Czech Health Research Council, grants No 16-29148A, NV19-04-00270, and NU22-04-00389.”

FundingFind in source

PASSReviewer 2· 90% conf

The trial is registered, methods are detailed, limitations are discussed, and funding/COI are disclosed.

Evidence

“Trial registration Clinicaltrials.gov NCT02398734”

AbstractFind in source

LimitationsFind in source

“The study was partially founded by the Czech Health Research Council, grants No 16-29148A, NV19-04-00270, and NU22-04-00389.”

FundingFind in source

Registered (1 ID: ClinicalTrials.gov). No reporting guideline cited.

Broken references and links

None found

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.

Checked — nothing surfaced.

Checked 33 references by DOI: 31 verified — 2 no DOI (shown, not verified).

1 data/code link checked; 1 live.

Copyediting

6 minor

Wording, consistency and formatting errors that need correcting before submission.

No major wording or formatting errors. 6 minor suggestions below.

6 copyedit issues flagged: mostly typo, consistency, grammar.

Kaimen Rigor Action ItemsFinal pass before journal submission

The published work is robust and well-reported. An informed reader should weigh the minor reporting gaps (e.g., unspecified software version, lack of explicit CONSORT statement) and the single-trial basis for the efficacy claim. No erratum is warranted for the identified issues, but the authors could consider a correction to clarify the percentage-point reduction and fix the 'founded' typo.

1.
HIGHreporting
In the Discussion, temper the claim that sonolysis 'should be used' to reduce periprocedural cerebrovascular events, as this is based on a single trial and may be premature; recommend replication before routine use.
The claim audit rated this claim as 'overstated' because the evidence supports efficacy but not necessarily a recommendation for routine use.
2.
HIGHreporting
In the Methods, explicitly state the version of R and any packages used for statistical analysis.
Both reviewers noted that the software version is not specified, which hampers reproducibility.
3.
HIGHreporting
In the Methods or Discussion, explicitly state adherence to the CONSORT reporting guideline.
Reviewer 2 noted that a reporting guideline is not explicitly mentioned, though the paper follows CONSORT-like structure.
4.
MEDIUMreporting
In the Methods, add a brief statement on how outliers or protocol deviations were handled in the analysis.
Reviewer 2 flagged outlier handling as 'reported_but_inadequate'.
5.
MEDIUMethics
In the Ethics section, explicitly mention compliance with the Declaration of Helsinki or ICH-GCP guidelines.
Reviewer 2 noted that regulatory compliance is not explicitly named.
6.
MEDIUMdata code
In the Data Availability Statement, provide a specific version or DOI for the code repository to enhance code sharing.
Reviewer 2 suggested providing a version or DOI for the code to improve reproducibility.
7.
MEDIUMcopyedit
In the Abstract, change 'founded' to 'funded' in the funding statement.
Copyedit flagged a typo in the funding statement.
8.
MEDIUMcopyedit
In the Discussion, clarify that the risk reduction is in percentage points, not relative percent, by rephrasing 'lower by 5.5%' to 'lower by 5.5 percentage points'.
Copyedit flagged this as potentially misleading.
9.
LOWcopyedit
In Table 1, change 'Calcificated' to 'Calcified' for consistency.
Copyedit flagged inconsistent terminology for plaque type.
10.
LOWcopyedit
In the Abstract, consider using 'vs.' instead of 'v' for consistency.
Copyedit flagged a minor style issue.
11.
LOWcopyedit
In Table 1, ensure the 'Unclassified' row is clearly defined and consistent with the total n.
Copyedit noted that the unclassified counts are not percentages, which may be confusing.
12.
LOWcopyedit
In the Discussion, consider rephrasing the sentence about the mechanism of sonolysis for clarity.
Copyedit suggested a minor grammatical improvement.

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Sonolysis during carotid endarterectomy: randomised controlled trial.

Školoudík D, Hrbáč T, Kovář M, Beneš V 3rd, Fiedler J, Branca M, Rossel JB, Netuka D, SONOBIRDIE Trial Investigators

Read full text (PMC)

DOI

10.1136/bmj-2024-082750

Share this Kaimen Rigor review

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Record fingerprint

7f6b448cfca801d6f711182c95d4cd7b002902ec168c9f6465ccffccca7a80b0

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

3 / 5

Adequate — real issues to address

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

IntegrityIntegrity concern ×3−1.5★
ClaimsOverstated claim−0.5★

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

Not verified in this report

The numeric-impossibility checks (GRIM/GRIMMER/DEBIT/SPRITE) did not run: 6 reported means were read, and their group size is not stated where the values are printed (this source has no machine-readable table structure). These checks need the count the mean was averaged over, so none was performed.

Biggest issues

01Conclusion reaches beyond the evidence
mediumOverreachreviewer-assessedFull detail
Sonolysis should be used to reduce periprocedural cerebrovascular events during carotid endarterectomy.
“The results of the SONOBIRDIE trial suggest that sonolysis should be used to reduce the risk of periprocedural cerebrovascular events during carotid endarterectomy in all patients with sufficient temporal bone window for transcranial Doppler.”
DiscussionFind in source

Findings by category

101ArithmeticNumerical inconsistencies 102OverreachOverstated conclusions 103AuthenticityData authenticity concerns 04DisclosureNone found 05AvailabilityNone found 06Copyedit6 minor suggestions

Numerical inconsistencies

1 finding · worst low

Internal contradictions in the reported numbersAssessed

Recomputed 2 tests: 2 consistent, 0 inconsistent; 2 via agent-written checks.

Overstated conclusions

1 finding · worst medium

Conclusions overstated beyond the evidenceAssessed

5 major claims checked against the paper's own evidence: 1 not fully backed by the presented evidence (unsupported or overstated).

Efficacy claim is anchored to an adequate endpoint and a meaningful effect.

Data authenticity concerns

1 finding · worst low

Other integrity concernAssessed

3 integrity concerns flagged (0 high).

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 with extensive prior work and a logical hypothesis.

Evidence

“Since the 1970s, in vitro and animal model studies have shown acceleration of thrombus dissolution by use of an ultrasound beam.”

Introduction ¶1Find in source

Introduction ¶3Find in source

Discussion ¶2Find in source

PASSReviewer 2· 90% conf

The paper establishes a clear scientific premise with extensive prior work and a logical rationale for the hypothesis.

Evidence

“Since the 1970s, in vitro and animal model studies have shown acceleration of thrombus dissolution by use of an ultrasound beam.”

Introduction ¶1Find in source

paraphrase[Introduction, paragraph 4]

paraphrase[Introduction, paragraph 3]

“Pilot studies have shown a potential positive effect of sonolysis on reduction of the risk of stroke or brain infarction during interventions.”

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· 95% conf

The trial design is rigorous with proper randomisation, blinding, sample size calculation, and pre-specified criteria.

Evidence

“Consecutive patients were assigned to the sonolysis group or the control group by computer generated one-to-one randomisation using an independent online randomisation system.”

MethodsFind in source

“Only the sonographer was not blinded to the application of sonolysis or sham procedure.”

MethodsFind in source

“A χ 2 test indicated that 1342 patients (671 per group) were needed to detect such a difference with a two sided α level of 0.05 and a power of 80%.”

Statistical analysisFind in source

PASSReviewer 2· 95% conf

The trial design is rigorous with adequate randomisation, blinding, sample size calculation, and pre-specified criteria.

Evidence

“Consecutive patients were assigned to the sonolysis group or the control group by computer generated one-to-one randomisation using an independent online randomisation system.”

MethodsFind in source

“Only the sonographer was not blinded to the application of sonolysis or sham procedure.”

MethodsFind in source

“A χ 2 test indicated that 1342 patients (671 per group) were needed to detect such a difference with a two sided α level of 0.05 and a power of 80%.”

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

Demographic and clinical characteristics are well reported, including sex, age, and health status.

Evidence

“1004 patients (mean age 68 years; 312 (31%) female) were enrolled”

AbstractFind in source

paraphrase[Table 1]

“Age, years: Mean (SD) | 68 (8.0) | 68 (7.7)”

PASSReviewer 2· 90% conf

Demographic and clinical characteristics are well reported, including age, sex, and comorbidities.

Evidence

“1004 patients (mean age 68 years; 312 (31%) female) were enrolled”

Table 1Find in source

“Arterial hypertension | 432 (85) | 448 (90)”

Table 1Find 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 approval and informed consent are clearly documented.

Evidence

“The protocol was approved by the multicentre ethics committee of Vítkovice Hospital (2 June 2015) and local institutional review boards of the participating centres.”

EthicsFind in source

“All patients provided written informed consent.”

EthicsFind in source

PASSReviewer 2· 95% conf

Ethical approval and informed consent are clearly documented.

Evidence

“The protocol was approved by the multicentre ethics committee of Vítkovice Hospital (2 June 2015) and local institutional review boards of the participating centres.”

EthicsFind in source

“All patients provided written informed consent.”

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· 85% conf

The investigational device (ultrasound machine and probe) is adequately identified, and statistical software is named.

Evidence

“Sonolysis in the SONOBIRDIE trial was performed using a standard ultrasound machine and 2 MHz transcranial Doppler probe.”

MethodsFind in source

paraphrase[Methods, Statistical analysis]

“The statistical analysis section mentions the use of R software (version not specified).”

PASSReviewer 2· 85% conf

The investigational device (ultrasound machine and probe) is adequately identified, and statistical software is mentioned.

Evidence

“Sonolysis in the SONOBIRDIE trial was performed using a standard ultrasound machine and 2 MHz transcranial Doppler probe.”

MethodsFind in source

“The code used to analyse the data in the paper can be found in the supplemental files.”

Data availabilityFind 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 comprehensive, with named tests, exact p-values, effect sizes with CIs, and appropriate data presentation.

Evidence

paraphrase[Abstract]

“P<0.001”

“risk difference −5.5%, 95% confidence interval (CI) −8.3% to −2.8%”

AbstractFind in source

paraphrase[Methods, Statistical analysis]

“The statistical analysis section mentions the use of R software (version not specified).”

PASSReviewer 2· 90% conf

Statistical methods are appropriate and well described, with exact p-values and confidence intervals reported.

Evidence

“We used a χ 2 test to compare the groups.”

Statistical analysisFind in source

paraphrase[Abstract and Results]

“P<0.001”

“risk difference −5.5%, 95% confidence interval (CI) −8.3% to −2.8%”

AbstractFind in source

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 are openly available with a persistent identifier.

Evidence

“The data underlying the findings in this paper are openly and publicly available and can be found here: https://data.mendeley.com/datasets/gkzrhyc6tj/1”

Data availabilityFind in source

“The code used to analyse the data in the paper can be found in the supplemental files.”

Data availabilityFind in source

PASSReviewer 2· 95% conf

Data and code are openly available with a persistent identifier.

Evidence

“The data underlying the findings in this paper are openly and publicly available and can be found here: https://data.mendeley.com/datasets/gkzrhyc6tj/1”

Data availabilityFind in source

“The code used to analyse the data in the paper can be found in the supplemental files.”

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

The trial is registered, reporting guidelines are followed, limitations are discussed, and funding/COI are disclosed.

Evidence

“Trial registration Clinicaltrials.gov NCT02398734”

AbstractFind in source

LimitationsFind in source

“The study was partially founded by the Czech Health Research Council, grants No 16-29148A, NV19-04-00270, and NU22-04-00389.”

FundingFind in source

PASSReviewer 2· 90% conf

The trial is registered, methods are detailed, limitations are discussed, and funding/COI are disclosed.

Evidence

“Trial registration Clinicaltrials.gov NCT02398734”

AbstractFind in source

LimitationsFind in source

“The study was partially founded by the Czech Health Research Council, grants No 16-29148A, NV19-04-00270, and NU22-04-00389.”

FundingFind in source

Registered (1 ID: ClinicalTrials.gov). No reporting guideline cited.

Broken references and links

None found

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.

Checked — nothing surfaced.

Checked 33 references by DOI: 31 verified — 2 no DOI (shown, not verified).

1 data/code link checked; 1 live.

Copyediting

6 minor

Wording, consistency and formatting errors that need correcting before submission.

No major wording or formatting errors. 6 minor suggestions below.

6 copyedit issues flagged: mostly typo, consistency, grammar.

Kaimen Rigor Action ItemsFinal pass before journal submission

1.
HIGHreporting
In the Discussion, temper the claim that sonolysis 'should be used' to reduce periprocedural cerebrovascular events, as this is based on a single trial and may be premature; recommend replication before routine use.
The claim audit rated this claim as 'overstated' because the evidence supports efficacy but not necessarily a recommendation for routine use.
2.
HIGHreporting
In the Methods, explicitly state the version of R and any packages used for statistical analysis.
Both reviewers noted that the software version is not specified, which hampers reproducibility.
3.
HIGHreporting
In the Methods or Discussion, explicitly state adherence to the CONSORT reporting guideline.
Reviewer 2 noted that a reporting guideline is not explicitly mentioned, though the paper follows CONSORT-like structure.
4.
MEDIUMreporting
In the Methods, add a brief statement on how outliers or protocol deviations were handled in the analysis.
Reviewer 2 flagged outlier handling as 'reported_but_inadequate'.
5.
MEDIUMethics
In the Ethics section, explicitly mention compliance with the Declaration of Helsinki or ICH-GCP guidelines.
Reviewer 2 noted that regulatory compliance is not explicitly named.
6.
MEDIUMdata code
In the Data Availability Statement, provide a specific version or DOI for the code repository to enhance code sharing.
Reviewer 2 suggested providing a version or DOI for the code to improve reproducibility.
7.
MEDIUMcopyedit
In the Abstract, change 'founded' to 'funded' in the funding statement.
Copyedit flagged a typo in the funding statement.
8.
MEDIUMcopyedit
In the Discussion, clarify that the risk reduction is in percentage points, not relative percent, by rephrasing 'lower by 5.5%' to 'lower by 5.5 percentage points'.
Copyedit flagged this as potentially misleading.
9.
LOWcopyedit
In Table 1, change 'Calcificated' to 'Calcified' for consistency.
Copyedit flagged inconsistent terminology for plaque type.
10.
LOWcopyedit
In the Abstract, consider using 'vs.' instead of 'v' for consistency.
Copyedit flagged a minor style issue.
11.
LOWcopyedit
In Table 1, ensure the 'Unclassified' row is clearly defined and consistent with the total n.
Copyedit noted that the unclassified counts are not percentages, which may be confusing.
12.
LOWcopyedit
In the Discussion, consider rephrasing the sentence about the mechanism of sonolysis for clarity.
Copyedit suggested a minor grammatical improvement.

Full text (46,983 chars)Analyzed: Aug 15, 2026