Effectiveness of shared decision making strategies for stroke prevention among patients with atrial fibrillation: cluster randomized controlled trial.

Name: Αlpha¹ Rigor Record — Effectiveness of shared decision making strategies for stroke prevention among patients with atrial fibrillation: cluster randomized controlled trial.
Item: Effectiveness of shared decision making strategies for stroke prevention among patients with atrial fibrillation: cluster randomized controlled trial.
Rating: 94
Author: Αlpha¹

Ozanne EM, Barnes GD, Brito JP, Cameron KA, Cavanaugh KL, Greene T, Jackson EA, Montori VM, Steinberg BA, Witt DM, Noseworthy P, Passman RS, Kansal P, Crossley G, Roden DM, Christensen JT, Ariotti A, Jones AE, Bardsley T, Wu C, Fagerlin A, STEP-UP Writing Group

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Αlpha¹ Rigor Review — 3.25★ (Adequate), 0 critical, 3 high issues for “Effectiveness of shared decision making strategies for stroke prevention among patients with atrial fibrillation: cluster randomized 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

3.25 / 5

Adequate — real issues to address

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

IntegrityIntegrity concern−0.5★
ClaimsEfficacy rests on an unvalidated surrogate endpoint−0.5★
ClaimsTreatment effect not shown to be clinically meaningful−0.5★
ReportingData & code availability partially met−0.25★

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

Problems surfaced4 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 conclusions2

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
Treatment effect not shown to be clinically meaningfulAssessed

Reporting gaps1

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.

Data/code availability incompleteAssessed

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 cluster randomized trial with clear randomization, sample size justification, and transparent reporting. The main weaknesses are a vague data availability statement, lack of statistical software identification, and minor copyedit issues. Overall, the paper is methodologically sound and the findings are credible.

Both reviewers classified the study as interventional, which is appropriate for a cluster RCT. The key resources dimension was rated not applicable by one reviewer and pass by the other; I adopted 'pass' because the decision aids are investigational products. The statistics verification checked 6 tests, all consistent, but coverage is limited to tests with test statistics or effect estimates with CIs; other p-values were not machine-verified.

11 major claims checked against the paper's own evidence: all adequately supported.

Premise concern: surrogate not validated for clinical benefit; effect size not shown to be clinically meaningful.

Recomputed 6 tests: 6 consistent, 0 inconsistent; 1 recomputed directly from the reported test statistics, 5 via agent-written checks.

1 integrity concern flagged (0 high).

Reporting

Eight Dimensions7 pass · 1 warn

The introduction cites prior research on decision aids and identifies a gap in comparative effectiveness. The rationale linking the premise to the study objectives is clear. Limitations of prior research are implicitly addressed by the study design, though not explicitly detailed.

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedINADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

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

Evidence

direct quote[Introduction, paragraph 4]

“Evidence has shown the effectiveness of a patient decision aid or encounter decision aid in improving shared decision making outcomes in a clinical setting ; however, no reliable estimate exists of the comparative effectiveness of these different types of decision aids in supporting shared decision making in practice.”