Sonolysis during carotid endarterectomy: randomised controlled trial.

Name: Αlpha¹ Rigor Record — Sonolysis during carotid endarterectomy: randomised controlled trial.
Item: Sonolysis during carotid endarterectomy: randomised controlled trial.
Rating: 100
Author: Αlpha¹

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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Αlpha¹ Rigor Review — 3★ (Adequate), 0 critical, 3 high issues for “Sonolysis during carotid endarterectomy: randomised controlled trial.”

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Αlpha¹ Editorial

This rigor review was examined and confirmed by Αlpha¹ Editorial · August 15, 2026

Αlpha¹ Rigor Review

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.

Problems surfaced3 types

Numerical inconsistencies1

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

Overstated conclusions1

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

Data authenticity concerns1

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

This Αlpha¹ Rigor Review uses AI 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'.

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.

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

3 integrity concerns flagged (0 high).

Reporting

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

direct quote[Introduction, paragraph 1]

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