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Kaimen Rigor review

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

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

DOI: 10.1136/bmj-2024-079976
Record issued: 2026-08-15
Engine: 7.39.0
Exported: 2026-09-20

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/26faa9b0-6b01-477c-b4b0-656ac65de8aa is authoritative.

Kaimen Rigor review

Kaimen 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

Biggest issues

01Efficacy rests on an unvalidated surrogate endpoint
highOverreachreviewer-assessedFull detail
The primary outcomes are surrogate measures of shared decision making (OPTION12 score, knowledge, decisional conflict) rather than hard clinical outcomes. The paper does not demonstrate target engagement at the tested dose (not applicable for a behavioral intervention) nor cite validated evidence linking these surrogates to clinical outcomes such as stroke prevention or patient-important outcomes. The claim of effectiveness rests on these surrogates without establishing a validated link to clinical benefit.
“Primary outcome measures were quality of shared decision making measured by OPTION12, knowledge of atrial fibrillation and its management, and decisional conflict.”
Find in source
02Treatment effect not shown to be clinically meaningful
highOverreachreviewer-assessedFull detail
The reported effect sizes are small relative to the scale ranges and lack anchoring to clinically meaningful thresholds. For example, the OPTION12 score improved by 12.1 points on a 0-100 scale, knowledge odds ratio 1.68, and decisional conflict reduced by 6.3 points on a 0-100 scale. The paper does not provide a minimal clinically important difference or other anchor to establish that these changes are clinically material. The discussion mentions a threshold for decisional conflict (<25) but does not use it to interpret the effect size.
“Compared with usual care, the combined use of both the patient decision aid and the encounter decision aid improved the quality of shared decision making (adjusted mean difference 12.1 (95% confidence interval (CI) 8.0 to 16.2; P<0.001), improved patients’…”
Find in source

Findings by category

101ArithmeticNumerical inconsistencies 202OverreachOverstated conclusions 03AuthenticityNone found 104DisclosureReporting gaps 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 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.

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

Agent-written checks— recomputed from reported CIs / ratios by code the agent wrote

CONSISTENTreported p < .001 · recomputed p = <.001
Recomputed odds ratio 1.68 (95% CI 1.35–2.09), reported p<0.001
“odds ratio 1.68 (95% CI 1.35 to 2.09; P<0.001”
Find in source
Taken as given: 1.35–2.09 is a two-sided 95% confidence interval for the odds ratio of 1.68, not a range, an IQR, or a different interval level; the odds ratio is a RATIO measure, so the interval is symmetric on the log scale; p<0.001 is the p for THIS estimate, not for another comparison in the same sentence
Method: back the two-tailed p out of the log-scale CI width and compare it against the printed p
How we recomputed it: pCI(1.68, 1.35, 2.09, 1)
CONSISTENTreported p < .001 · recomputed p = <.001Reviewer 1
Primary comparison for OPTION12: estimated difference 12.1, 95% CI 8.0 to 16.2, p<0.001
“adjusted mean difference 12.1 (95% confidence interval (CI) 8.0 to 16.2; P<0.001)”
Find in source
Taken as given: The estimate is a mean difference.; The CI is two-sided at 95%.
Method: Recomputed p-value from estimate and 95% CI using normal approximation.
How we recomputed it: pCI(12.1, 8.0, 16.2, 0)
CONSISTENTreported p < .001 · recomputed p = <.001Reviewer 1
Primary comparison for decisional conflict: estimated difference -6.3, 95% CI -9.6 to -3.1, p<0.001
“adjusted mean difference −6.3 (95% CI −9.6 to −3.1; P<0.001)”
Find in source
Taken as given: The estimate is a mean difference.; The CI is two-sided at 95%.
Method: Recomputed p-value from estimate and 95% CI using normal approximation.
How we recomputed it: pCI(-6.3, -9.6, -3.1, 0)
CONSISTENTreported p < .001 · recomputed p = <.001Reviewer 2
Primary comparison for OPTION12: EDA and PDA vs control
“estimated difference 12.1, 95% confidence interval (CI) 8.0 to 16.2; P<0.001”
Find in source
Taken as given: The estimate is a mean difference with a 95% CI.; The CI is two-sided.
Method: Recomputed p-value from the estimate and 95% CI using normal approximation.
How we recomputed it: pCI(12.1, 8.0, 16.2, 0)
CONSISTENTreported p < .001 · recomputed p = <.001Reviewer 2
Primary comparison for knowledge: EDA and PDA vs control
“adjusted odds ratio comparing the proportion of correct responses on the knowledge score 1.68, 95% CI 1.35 to 2.09; P<0.001”
Find in source
Taken as given: The estimate is an odds ratio with a 95% CI.; The CI is two-sided.
Method: Recomputed p-value from the log odds ratio and its 95% CI using normal approximation.
How we recomputed it: pCI(1.68, 1.35, 2.09, 1)
CONSISTENTreported p < .001 · recomputed p = <.001Reviewer 2
Primary comparison for decisional conflict: EDA and PDA vs control
“estimated difference −6.3, 95% CI −9.6 to −3.1, P<0.001”
Find in source
Taken as given: The estimate is a mean difference with a 95% CI.; The CI is two-sided.
Method: Recomputed p-value from the estimate and 95% CI using normal approximation.
How we recomputed it: pCI(-6.3, -9.6, -3.1, 0)

lowinternal contradiction
The abstract states '1117 participants across six sites were included in the analysis' but the results section reports 1214 enrolled and 97 excluded, which sums to 1117, consistent. No contradiction found.
“1117 participants across six sites were included in the analysis.”
AbstractFind in source

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
Treatment effect not shown to be clinically meaningfulAssessed

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

supportedReviewer 1
Combined use of both decision aids improves quality of shared decision making, knowledge, and reduces decisional conflict compared to usual care.
The primary analysis shows statistically significant improvements for all three outcomes.
Evidence: Adjusted mean difference 12.1 (95% CI 8.0 to 16.2; P<0.001) for OPTION12; odds ratio 1.68 (95% CI 1.35 to 2.09; P<0.001) for knowledge; adjusted mean difference −6.3 (95% CI −9.6 to −3.1; P<0.001) for decisional conflict.
“Compared with usual care, the combined use of both the patient decision aid and the encounter decision aid improved the quality of shared decision making (adjusted mean difference 12.1 (95% confidence interval (CI) 8.0 to 16.2; P<0.001), improved patients’ knowledge (odds ratio 1.68 (95% CI 1.35 to 2.09; P<0.001), and reduced patients’ decisional conflict (adjusted mean difference −6.3 (95% CI −9.6 to −3.1; P<0.001).”
AbstractFind in source
supportedReviewer 1
Encounter decision aid alone improves all three outcomes compared to usual care.
Secondary analysis shows significant improvements for all three outcomes.
Evidence: OPTION12 estimated difference 12.9 (8.6 to 17.1; P<0.001); knowledge OR 1.41 (1.11 to 1.79; P=0.003); decisional conflict −5.8 (−9.3 to −2.4; P<0.001).
EDA v control 12.9 (8.6 to 17.1) ... P<0.001 ... 1.41 (1.11 to 1.79) ... 0.003 ... −5.8 (−9.3 to −2.4) ... <0.001
Table 3reviewer’s wording
supportedReviewer 1
Patient decision aid alone improves shared decision making and knowledge but not decisional conflict.
Secondary analysis shows significant improvements for OPTION12 and knowledge, but not for decisional conflict.
Evidence: OPTION12 estimated difference 3.8 (1.1 to 6.4; P<0.001); knowledge OR 1.68 (1.24 to 2.28; P<0.001); decisional conflict −2.6 (−6.8 to 1.6; P=0.11).
PDA v control 3.8 (1.1 to 6.4) ... <0.001 ... 1.68 (1.24 to 2.28) ... <0.001 ... −2.6 (−6.8 to 1.6) ... 0.11
Table 3reviewer’s wording
supportedReviewer 1
No important differences were observed in treatment choices or satisfaction.
Secondary outcomes show no significant differences across groups.
Evidence: Table 5 shows no significant differences in agreement, clinician recommendation, or satisfaction.
“No statistically significant differences when comparing clinician-patient agreement on treatment choice by group”
Table 5Find in source
supportedReviewer 1
The study is the largest randomized controlled trial of decision aids and the first to directly compare complementary patient and encounter decision aids.
The paper claims this and no contradicting evidence is presented.
Evidence: Statement in Discussion.
“To our knowledge, this is the largest randomized controlled trial of decision aids and the first to directly compare the use of a complementary patient decision aid and encounter decision aid.”
DiscussionFind in source
supportedReviewer 2
The combined use of both the patient decision aid and the encounter decision aid improved the quality of shared decision making.
The primary comparison shows a statistically significant improvement in OPTION12 score.
Evidence: Adjusted mean difference 12.1 (95% CI 8.0 to 16.2; P<0.001) for EDA and PDA vs control.
“the combined use of both the patient decision aid and the encounter decision aid improved the quality of shared decision making (adjusted mean difference 12.1 (95% confidence interval (CI) 8.0 to 16.2; P<0.001)”
AbstractFind in source
supportedReviewer 2
The combined use of both decision aids improved patients' knowledge.
The primary comparison shows a statistically significant improvement in knowledge.
Evidence: Odds ratio 1.68 (95% CI 1.35 to 2.09; P<0.001) for EDA and PDA vs control.
“improved patients’ knowledge (odds ratio 1.68 (95% CI 1.35 to 2.09; P<0.001)”
AbstractFind in source
supportedReviewer 2
The combined use of both decision aids reduced patients' decisional conflict.
The primary comparison shows a statistically significant reduction in decisional conflict.
Evidence: Adjusted mean difference −6.3 (95% CI −9.6 to −3.1; P<0.001) for EDA and PDA vs control.
“reduced patients’ decisional conflict (adjusted mean difference −6.3 (95% CI −9.6 to −3.1; P<0.001)”
AbstractFind in source
supportedReviewer 2
The encounter decision aid alone versus usual care showed statistically significant improvements for all three outcomes.
Secondary comparisons show significant improvements for EDA vs control on all three outcomes.
Evidence: Table 3: EDA vs control OPTION12 diff 12.9 (8.6 to 17.1) P<0.001; knowledge OR 1.41 (1.11 to 1.79) P=0.003; decisional conflict diff −5.8 (−9.3 to −2.4) P<0.001.
“Statistically significant improvements were also observed with the encounter decision aid alone versus usual care for all three outcomes”
AbstractFind in source
supportedReviewer 2
The patient decision aid alone versus usual care showed statistically significant improvements for quality of shared decision making and knowledge.
Secondary comparisons show significant improvements for PDA vs control on OPTION12 and knowledge, but not decisional conflict.
Evidence: Table 3: PDA vs control OPTION12 diff 3.8 (1.1 to 6.4) P<0.001; knowledge OR 1.68 (1.24 to 2.28) P<0.001; decisional conflict diff −2.6 (−6.8 to 1.6) P=0.11.
“with the patient decision aid alone versus usual care for quality of shared decision making and knowledge”
AbstractFind in source
supportedReviewer 2
No important differences were observed in treatment choices for stroke prevention or in participants' satisfaction.
Secondary outcomes show no significant differences in treatment choice or satisfaction.
Evidence: Table 5 shows no significant differences in agreement, clinician recommendation, or satisfaction.
“No important differences were observed in treatment choices for stroke prevention or in participants’ satisfaction.”
AbstractFind in source

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

INADEQUATESurrogate endpoint
The primary outcomes are surrogate measures of shared decision making (OPTION12 score, knowledge, decisional conflict) rather than hard clinical outcomes. The paper does not demonstrate target engagement at the tested dose (not applicable for a behavioral intervention) nor cite validated evidence linking these surrogates to clinical outcomes such as stroke prevention or patient-important outcomes. The claim of effectiveness rests on these surrogates without establishing a validated link to clinical benefit.
“Primary outcome measures were quality of shared decision making measured by OPTION12, knowledge of atrial fibrillation and its management, and decisional conflict.”
Find in source
INADEQUATEEffect size
The reported effect sizes are small relative to the scale ranges and lack anchoring to clinically meaningful thresholds. For example, the OPTION12 score improved by 12.1 points on a 0-100 scale, knowledge odds ratio 1.68, and decisional conflict reduced by 6.3 points on a 0-100 scale. The paper does not provide a minimal clinically important difference or other anchor to establish that these changes are clinically material. The discussion mentions a threshold for decisional conflict (<25) but does not use it to interpret the effect size.
“Compared with usual care, the combined use of both the patient decision aid and the encounter decision aid improved the quality of shared decision making (adjusted mean difference 12.1 (95% confidence interval (CI) 8.0 to 16.2; P<0.001), improved patients’ knowledge (odds ratio 1.68 (95% CI 1.35 to 2.09; P<0.001), and reduced patients’ decisional conflict (adjusted mean difference −6.3 (95% CI −9.6 to −3.1; P<0.001).”
Find in source

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

1 finding · worst medium

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

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

“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.”

Introduction ¶4Find in source

“The aim of this study was to evaluate the effectiveness of a patient decision aid and an encounter decision aid in promoting high quality shared decision making for stroke prevention in the care of patients with non-valvular atrial fibrillation at risk of stroke.”

Introduction ¶4Find in source

absence[Introduction]

Limitations of prior research are not explicitly discussed.

PASSReviewer 2· 90% conf

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

Evidence

Introduction ¶3Find in source

absence[Introduction]

Limitations of prior research are not explicitly discussed.

Randomization method and unit are clearly described (patients and clinicians randomized, stratified by site and other factors). Blinding is described as not possible for participants, but outcome assessors were not blinded (noted as a limitation). Power analysis is provided with assumptions. Inclusion/exclusion criteria are detailed. Outlier handling is addressed through imputation and intention-to-treat analysis. Controls are the usual care group. Independent replication is not applicable for a single trial.

Sub-criteria

controlsADEQUATE

power analysisADEQUATE

blinding levelsINADEQUATE

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 appropriate randomization, blinding considerations, and sample size justification.

Evidence

“Patients were randomly assigned with equal allocation to either the use of the patient decision aid or usual care. Clinicians were randomly assigned with equal allocation to either use the encounter decision aid with all study participants or a usual care arm in which they did not use the encounter decision aid for any study participants.”

MethodsFind in source

“Participants could not be blinded to allocation owing to the nature of the intervention.”

MethodsFind in source

“Under these assumptions, the sample size of 1200 would provide 80% power with a two sided α of 0.05 to detect mean differences, expressed as fractions of one standard deviation, of 0.40, 0.33, and 0.33 for the OPTION12, knowledge, and decisional conflict scores, respectively”

MethodsFind in source

PASSReviewer 2· 90% conf

The trial design is rigorous with appropriate randomization, blinding considerations, and sample size justification.

Evidence

“A study coordinator allocated all participants by using the REDCap randomization function.”

MethodsFind in source

“Participants could not be blinded to allocation owing to the nature of the intervention.”

MethodsFind in source

Sex, age, race/ethnicity, education, and health insurance are reported in Table 1. Age and sex are reported for the cohort. 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

Patient demographics and clinical characteristics are well reported.

Evidence

paraphrase[Table 1]

“Sex assigned at birth: Female 103/298 (35) ... Male 195/298 (65)”

“The mean age of the patients was 69 (standard deviation 9) years”

Results ¶1Find in source

PASSReviewer 2· 90% conf

Patient demographics and clinical characteristics are well reported.

Evidence

paraphrase[Table 1]

“Sex assigned at birth: Female 103/298 (35) ... Male 195/298 (65)”

“The mean age of the patients was 69 (standard deviation 9) years”

Results ¶1Find in source

The study has ethical approval from a named IRB with a protocol number, and informed consent was obtained from all participants. Regulatory compliance is implied through adherence to ethical standards, though not explicitly named.

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceINADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

Ethical approval and informed consent are clearly documented.

Evidence

“The study has ethical approval from the University of Utah Institutional Review Board (IRB_00124127).”

EthicsFind in source

“All participants provided informed consent before taking part in the study.”

EthicsFind in source

PASSReviewer 2· 95% conf

Ethical approval and informed consent are clearly documented.

Evidence

“The study has ethical approval from the University of Utah Institutional Review Board (IRB_00124127).”

EthicsFind in source

“All participants provided informed consent before taking part in the study.”

EthicsFind in source

The decision aids are described in detail, though not with a manufacturer/catalog number as they are custom tools. Statistical software is not explicitly named, but the analysis methods are described. No wet-lab reagents are used.

Sub-criteria

mycoplasma testingN/A

reagents identifiedADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedINADEQUATE

Per reviewer (2) — the votes behind the verdict

N/AReviewer 1· 90% conf

The study uses decision aids as interventions, which are not typical biological/chemical resources; no investigational drug or device is involved.

Evidence

“The patient decision aid was designed as an interactive, non-linear online tool”

MethodsFind in source

PASSReviewer 2· 85% conf

The investigational products (decision aids) are described, and software tools are identified.

Evidence

“The patient decision aid includes an explanation of atrial fibrillation and how it affects a patient’s life and features the CHA 2 DS 2 -VASc and HAS-BLED calculators”

MethodsFind in source

absence[Methods, Statistical analyses]

Statistical software is not explicitly named.

Statistical tests are named (linear mixed effects models, generalized linear mixed effects models). Assumptions are handled through model design. Exact p-values are reported for primary outcomes. Effect sizes with confidence intervals are provided. Software is not explicitly identified. Data presentation includes means, SDs, and CIs. Mathematical plausibility checks were not performed due to lack of raw data.

Sub-criteria

tests namedADEQUATE

exact p valuesADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedNOT REPORTED

assumptions verifiedADEQUATE

mathematical plausibilityN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Statistical methods are appropriate and well described, with effect sizes and confidence intervals reported.

Evidence

“We did the co-primary statistical analyses for the OPTION12 scale and Decisional Conflict Scale by using separate analyses of linear mixed effects models”

MethodsFind in source

paraphrase[Results, Table 3]

“12.1 (8.0 to 16.2) ... P<0.001”

PASSReviewer 2· 90% conf

Statistical methods are appropriate and well described, with effect sizes and confidence intervals reported.

Evidence

“We did the co-primary statistical analyses for the OPTION12 scale and Decisional Conflict Scale by using separate analyses of linear mixed effects models”

MethodsFind in source

paraphrase[Results, Table 3]

“12.1 (8.0 to 16.2) ... P<0.001”

absence[Methods]

Statistical software is not identified.

The data availability statement says de-identified data will be posted to ClinicalTrials.gov, but no timeline or accession number is provided. Additional data may be shared on reasonable request, but no mechanism is specified. No code is shared.

Sub-criteria

code sharingNOT REPORTED

accession numbersNOT REPORTED

repository depositNOT REPORTED

data availability statementINADEQUATE

Per reviewer (2) — the votes behind the verdict

WARNReviewer 1· 80% conf

Data availability statement is present but vague; no repository deposit or code sharing.

Evidence

“De-identified data will be posted to ClinicalTrials.gov according to our sponsors’ requirements and timeline. Additional data may be shared on reasonable request.”

Data availabilityFind in source

WARNReviewer 2· 80% conf

Data availability statement is present but vague, and no code is shared.

Evidence

“De-identified data will be posted to ClinicalTrials.gov according to our sponsors’ requirements and timeline. Additional data may be shared on reasonable request.”

Data availabilityFind in source

absence[Data availability statement]

No code sharing mentioned.

Trial registration is provided. CONSORT diagram is included. All outcomes are reported, including non-significant ones. Limitations are discussed. Conclusions are proportional to evidence. Funding and COI statements are provided.

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 manuscript is transparent with trial registration, CONSORT diagram, and limitations discussed.

Evidence

“Trial registration ClinicalTrials.gov NCT04357288”

AbstractFind in source

“Fig 2 CONSORT (Consolidated Standards of Reporting Trials) diagram.”

Figure 2Find in source

“Observers assessing the OPTION12 outcome measure on video recorded encounters cannot be blinded to allocation; their unblinded assessments could be biased in favor of decision aids”

LimitationsFind in source

PASSReviewer 2· 90% conf

The trial is registered, reporting guidelines are followed, and limitations are discussed.

Evidence

“Trial registration ClinicalTrials.gov NCT04357288”

AbstractFind in source

“Fig 2 CONSORT (Consolidated Standards of Reporting Trials) diagram.”

Figure 2Find in source

“Observers assessing the OPTION12 outcome measure on video recorded encounters cannot be blinded to allocation; their unblinded assessments could be biased in favor of decision aids”

LimitationsFind in source

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

ClinicalTrials.gov

NCT04357288

Reporting guidelines: CONSORT

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 36 references by DOI: 31 verified — 5 no DOI (shown, not verified).

NO DOI
Atrial fibrillation and stroke: epidemiology
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Newly Detected Atrial Fibrillation: AAFP Updates Guideline on Pharmacologic Management
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Decision aids for people facing health treatment or screening decisions
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Linear Mixed Models for Longitudinal Data
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Digital Readiness Gaps
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).

1 data/code link checked; 1 live.

datahttps://clinicaltrials.gov/ct2/show/NCT04357288LIVEHTTP 200
Resolves, but the content could not be matched to the paper.

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 consistency, clarity, typo.

MINORtypoAbstract
“Ozanne Elissa M associate professor”
→ Format author names consistently, e.g., 'Elissa M Ozanne, associate professor'
Author list formatting is inconsistent.
MINORconsistencyMethods, Randomization and blinding
“Participants could not be blinded to allocation owing to the nature of the intervention.”
→ Clarify whether outcome assessors were blinded.
Blinding of assessors is not explicitly stated.
MINORclarityResults, Table 1
“Positive for limited reading ability 31/291 (11)”
→ Define 'limited reading ability' in the table footnote.
Term not defined.
MINORconsistencyAbstract
“P<0.001”
→ Use consistent formatting for p-values (e.g., P<0.001 vs p<0.001).
Inconsistent capitalization of P in p-values.
MINORclarityMethods, Sample size
“The minimum detectable effect sizes were 0.41, 0.34, and 0.34, respectively, for encounter decision aid versus usual care and 0.29, 0.29, and 0.29, respectively, for patient decision aid versus usual care, using the α levels described below.”
→ Clarify which outcome each effect size corresponds to.
Ambiguous which effect size is for which outcome.
MINORgrammarIntroduction
“as many as 50% of at risk patients with atrial fibrillation who are given a prescription for an oral anticoagulants do not start therapy”
→ Change 'an oral anticoagulants' to 'an oral anticoagulant'.
Subject-verb agreement error.

Kaimen Rigor Action ItemsFinal pass before journal submission

The published work is robust and credible, with no major integrity concerns. An informed reader should weigh the minor reporting gaps (vague data availability, missing software identification) and the unblinded outcome assessors as limitations, but these do not undermine the main conclusions. No erratum is warranted based on the checks performed.

1.
HIGHdata code
In the Data availability statement, specify the exact timeline for posting de-identified data to ClinicalTrials.gov and the process for requesting additional data (e.g., contact email or data access committee).
The current statement is vague and does not meet common reproducibility standards.
2.
HIGHstatistics
In the Methods, Statistical analyses section, name the statistical software and version used (e.g., R 4.2, SAS 9.4).
Software identification is a standard reporting requirement and was flagged by both reviewers.
3.
HIGHdata code
Share analysis code in a public repository (e.g., GitHub) and link it in the Data availability statement.
Code sharing enhances reproducibility and was recommended by both reviewers.
4.
MEDIUMreporting
In the Methods, Randomization and blinding section, explicitly state whether outcome assessors were blinded (or not) and any measures taken to mitigate bias.
The copyedit pass and reviewers noted that assessor blinding is not clearly described.
5.
MEDIUMreporting
In the Introduction, add a sentence discussing limitations of prior research that this study addresses.
Both reviewers flagged that limitations of prior work are not explicitly discussed.
6.
MEDIUMcopyedit
In the Abstract, standardize p-value formatting (e.g., use 'P<0.001' consistently) and fix the author name formatting (e.g., 'Elissa M Ozanne, associate professor').
Minor copyedit issues affect professionalism and consistency.
7.
MEDIUMcopyedit
In Table 1, define 'limited reading ability' in a footnote.
The term is not defined and could be ambiguous to readers.
8.
MEDIUMcopyedit
In the Methods, Sample size section, clarify which outcome each minimum detectable effect size corresponds to.
The current text is ambiguous about which effect size is for which outcome.
9.
LOWcopyedit
In the Introduction, fix the grammar error: change 'an oral anticoagulants' to 'an oral anticoagulant'.
Subject-verb agreement error.
10.
LOWethics
In the Ethics statements, add an explicit statement of adherence to the Declaration of Helsinki or equivalent ethical framework.
One reviewer noted regulatory compliance is only implied; explicit statement strengthens the ethics section.

Full text (53,535 chars)Analyzed: Aug 15, 2026

RigorReviewer 1

RigorReviewer 2

RigorPre-Submission Reviewer

CopyeditAgent Scribe

CitationsCitation Integrity

StatisticsStatistics Consistency

ReproducibilityLink verification (liveness + content)· no model (rule-based)

PreregistrationDeterministic check· no model (rule-based)

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.”

How stars are deducted

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.

The eight reporting dimensions

Scientific PremisePrior work, rationale, and how it addresses gaps.

Study Design & RigorRandomization, blinding, power, controls, replication.

Biological VariablesSex, age, species/strain, housing, demographics.

Ethical ApprovalsIRB/IACUC approval, informed consent, regulatory compliance.

Key ResourcesAntibodies, cell lines, organisms, software — identified with persistent IDs.

Statistical ReportingNamed tests, exact p-values, effect sizes, plausible summary stats.

Data & Code AvailabilityAvailability statements, repositories, accession numbers, shared code.

Reporting TransparencyMethods, registration, guidelines, outcomes, limitations, funding/COI.

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.

This Kaimen Rigor review is model-assisted and is not a substitute for formal expert review. It complements human evaluation by surfacing potential methodological concerns — verify each finding against the source.

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

DOI

10.1136/bmj-2024-079976

Record issued

2026-08-15

Engine

7.39.0

Exported

2026-09-20