Kaimen Rigor reviewed

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A village doctor-led mobile health intervention for cardiovascular risk reduction in rural China: cluster randomised controlled trial.

Name: Kaimen Rigor review — A village doctor-led mobile health intervention for cardiovascular risk reduction in rural China: cluster randomised controlled trial.
Item: A village doctor-led mobile health intervention for cardiovascular risk reduction in rural China: cluster randomised controlled trial.
Rating: 96
Author: Alpha1

Zhang X, Wang S, Zhou X, Tang Y, Xing L, Ma S, Xu Y, Wu C, Cui J, Yang Y, Lin C, Wu Y, Zhang H, Fan L, Xu C, Li X, SMARTER Collaborative Group

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Kaimen Rigor review — 2★ (Weak), 0 critical, 3 high issues for “A village doctor-led mobile health intervention for cardiovascular risk reduction in rural China: cluster randomised controlled trial.”

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

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A village doctor-led mobile health intervention for cardiovascular risk reduction in rural China: cluster randomised controlled trial.

Zhang X, Wang S, Zhou X, Tang Y, Xing L, Ma S, Xu Y, Wu C, Cui J, Yang Y, Lin C, Wu Y, Zhang H, Fan L, Xu C, Li X, SMARTER Collaborative Group

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DOI

10.1136/bmj-2024-082765

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Kaimen Rigor reviewed

Rigor-Reviewed Manuscript

A village doctor-led mobile health intervention for cardiovascular risk reduction in rural China: cluster randomised controlled trial.

Zhang X, Wang S, Zhou X, Tang Y, Xing L, Ma S, Xu Y, Wu C, Cui J, Yang Y, Lin C, Wu Y, Zhang H, Fan L, Xu C, Li X, SMARTER Collaborative Group

Paper source

A village doctor-led mobile health intervention for cardiovascular risk reduction in rural China: cluster randomised controlled trial.

Read full text (PMC)

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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 / 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★
ClaimsTreatment effect not shown to be clinically meaningful−0.5★
ReportingData & code availability partially met−0.25★
CitationsUnresolved reference−0.25★

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

Not verified in this report

No data or code availability links were detected to verify.

Biggest issues

01Efficacy rests on an unvalidated surrogate endpoint
highOverreachreviewer-assessedFull detail
The primary outcome is the change in predicted 10-year ASCVD risk using the China-PAR model, which is a surrogate for clinical cardiovascular events. The paper does not provide evidence linking this surrogate to hard clinical outcomes, nor does it demonstrate target engagement at the tested dose (the intervention is behavioral, not a drug). The efficacy claim rests on this surrogate without validation of its clinical meaningfulness.
“The primary outcome was mean change in 10 year risk of ASCVD based on the China-PAR model from baseline to the 12 month visit”
Find in source
02Treatment effect not shown to be clinically meaningful
highOverreachreviewer-assessedFull detail
The primary effect is a 1.88% absolute reduction in predicted 10-year ASCVD risk, which is a small fraction of the baseline risk (18.0% to 11.7% in intervention vs 17.8% to 13.6% in control). The paper does not anchor this to a minimal clinically important difference or demonstrate that this reduction translates into meaningful clinical benefit. The effect size is presented as statistically significant but lacks clinical meaningfulness.
“absolute difference −1.88% (95% confidence interval (CI) −2.57% to −1.19%; P<0.001)”
Find in source

Findings by category

101ArithmeticNumerical inconsistencies 302OverreachOverstated conclusions 203AuthenticityData authenticity concerns 104DisclosureReporting gaps 105AvailabilityBroken references and links · partly checked 06Copyedit7 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 cluster randomised controlled trial is methodologically rigorous, with a clear premise, robust design, and transparent reporting. The main weakness is the vague and incomplete data availability statement, which lacks a repository or clear access procedure.

Both reviewers agreed on study type (interventional). The evaluation covers all eight dimensions; no dimensions were excluded as not applicable. The statistics verification checked 10 tests and found all consistent; coverage is limited to tests with a test statistic and df or an effect estimate with CI.

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 10 tests: 10 consistent, 0 inconsistent; 1 recomputed directly from the reported test statistics, 9 via agent-written checks.

Overstated conclusions

3 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
Conclusions only partially backed by the presented evidenceAssessed

4 major claims checked against the paper's own evidence: 1 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; effect size not shown to be clinically meaningful.

Data authenticity concerns

2 findings · 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.

Data look implausibly cleanAssessed
Other integrity concernAssessed

3 integrity concerns flagged (0 high).

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 the burden of cardiovascular disease in China, suboptimal implementation of lifestyle modifications, and the scarcity of mHealth evidence for primary prevention. It identifies gaps in involving primary healthcare workforce and justifies the need for the SMARTER study. 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 adequate citation of prior work and a logical rationale for the study.

Evidence

“Mobile health (mHealth) tools appear promising in the secondary prevention of cardiovascular disease, but evidence on primary prevention, particularly based on randomised controlled trials, is scarce. More importantly, the primary healthcare workforce has rarely been involved, as those mHealth tools were primarily developed to support self-management.”

Introduction ¶1Find in source

“To meet practical needs and fill knowledge gaps, we developed a village doctor-led health management strategy featuring scalable tools based on mHealth technologies.”

Introduction ¶2Find in source

PASSReviewer 2· 90% conf

The paper establishes a clear scientific premise by citing prior research on cardiovascular disease burden, mHealth tools, and primary healthcare challenges, and logically links these to the study objectives.

Evidence

Introduction ¶1Find in source

“To meet practical needs and fill knowledge gaps, we developed a village doctor-led health management strategy featuring scalable tools based on mHealth technologies.”

Introduction ¶2Find in source

paraphrase[Introduction, paragraph 2]

“Paraphrase: The study aims to fill the gap by involving village doctors and using a cluster randomised design.”

Randomization used a central system with minimisation algorithm and random element. Allocation concealed from statisticians; participants and village doctors unblinded due to intervention nature, which is acceptable. Power analysis provided with assumptions and achieved power. Inclusion/exclusion criteria clearly defined. Outlier handling not explicitly described but missing data approach (ITT) is stated. Controls are the usual care group. Independent replication not applicable for a single trial.

Sub-criteria

controlsADEQUATE

power analysisADEQUATE

blinding levelsADEQUATE

outlier handlingINADEQUATE

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 cluster randomised design is rigorous with adequate randomization, blinding of statisticians, power analysis, and pre-specified inclusion/exclusion criteria.

Evidence

“Overall, 127 villages (clusters), stratified by counties, were randomly assigned (1:1) to either the intervention group or the control group using a central randomisation system.”

MethodsFind in source

“Allocation was, however, concealed from the study statisticians.”

MethodsFind in source

“The minimum sample size of 4200 participants in 120 villages (60 villages in each comparison group, and 35 participants in each village) was calculated for the primary outcome. We estimated that a study of this sample size would provide a statistical power of 90% at a two sided α of 0.05 to detect a 1.0% absolute difference (ie, 10% relative difference) in mean change in 10 year risk of ASCVD between the intervention and control groups at 12 months.”

Statistical analysisFind in source

PASSReviewer 2· 95% conf

The study design is rigorous with clear randomization, allocation concealment from statisticians, a priori sample size calculation, and pre-specified inclusion/exclusion criteria.

Evidence

“Overall, 127 villages (clusters), stratified by counties, were randomly assigned (1:1) to either the intervention group or the control group using a central randomisation system.”

MethodsFind in source

“The minimum sample size of 4200 participants in 120 villages (60 villages in each comparison group, and 35 participants in each village) was calculated for the primary outcome.”

Statistical analysisFind in source

“The inclusion criteria for participants were age ≥35 years with a predicted 10 year risk of atherosclerotic cardiovascular disease (ASCVD) of ≥10% based on the China-PAR (Prediction for ASCVD Risk in China) risk prediction model, ownership of a smartphone and understanding how to use basis apps, and contract with the local village doctor for family doctor services.”

MethodsFind in source

Sex is reported for all participants (50.3% women). Age, blood pressure, glucose, lipids, BMI, and other health indicators are reported. Demographics include age, sex, education, occupation, income, marital status, and insurance. Since both sexes are enrolled, sex_justified 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

“The mean age of participants was 57.7 (SD 8.2) years, 2282 (50.3%) were women”

ResultsFind in source

“At baseline, mean systolic and diastolic blood pressure was 157.4 (SD 16.2) mm Hg and 93.0 (SD 10.9) mm Hg, respectively, fasting blood glucose level was 7.1 (SD 2.6) mmol/L, and non-high density lipoprotein cholesterol level was 3.4 (SD 1.3) mmol/L.”

ResultsFind in source

PASSReviewer 2· 90% conf

Biological variables are well reported for a human trial, including sex, age, and health status; demographics are comprehensive.

Evidence

“The mean age of participants was 57.7 (SD 8.2) years, 2282 (50.3%) were women”

ResultsFind in source

“At baseline, mean systolic and diastolic blood pressure was 157.4 (SD 16.2) mm Hg and 93.0 (SD 10.9) mm Hg, respectively, fasting blood glucose level was 7.1 (SD 2.6) mmol/L”

ResultsFind in source

paraphrase[Table 1]

“Education: Primary school or lower 1881 (41.5) | Middle school 1696 (37.4) | High school 681 (15.0) | College or higher 275 (6.1)”

The trial was approved by the central ethics committee at Fuwai Hospital with approval number 2022-1781. Written informed consent was obtained from all participants. Regulatory compliance is implied by 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 adequately reported.

Evidence

“This trial was approved (approval No 2022-1781) by the central ethics committee at Fuwai Hospital, Beijing, China.”

EthicsFind in source

“Written informed consent was obtained from all participants before inclusion.”

MethodsFind in source

PASSReviewer 2· 95% conf

Ethical approval is explicitly stated with a named ethics committee and approval number, and informed consent was obtained.

Evidence

“This trial was approved (approval No 2022-1781) by the central ethics committee at Fuwai Hospital, Beijing, China.”

EthicsFind in source

“Written informed consent was obtained from all participants before inclusion.”

MethodsFind in source

absence[Ethics statements]

Regulatory compliance is not explicitly named.

The smart band (Huawei Band 4) is identified with manufacturer. The WeChat mini program and SAS 9.4 are named. No antibodies, cell lines, or organisms are used. Reagents are not applicable. Software tools are identified with version.

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 product (smart band) and software are identified; other bench resources are not applicable.

Evidence

“Each participant in the intervention group received a smart band (Huawei Band 4; Huawei Technologies, Dongguan, China).”

MethodsFind in source

“All analyses were conducted using SAS 9.4 (SAS Institute, Cary, NC).”

Statistical analysisFind in source

PASSReviewer 2· 85% conf

The investigational product (smart band) and software (SAS) are identified; no other biological/chemical resources are applicable.

Evidence

“Each participant in the intervention group received a smart band (Huawei Band 4; Huawei Technologies, Dongguan, China).”

MethodsFind in source

“All analyses were conducted using SAS 9.4 (SAS Institute, Cary, NC).”

Statistical analysisFind in source

Tests are named (linear mixed effects, generalized linear mixed effects, Cox frailty). Assumptions are handled by design (mixed models). Exact p-values are reported. Effect sizes with CIs are provided. Software identified. Data presentation includes per-group n and CIs. Mathematical plausibility checks: baseline percentages sum correctly; subgroup counts sum to totals; no arithmetic errors detected.

Sub-criteria

tests namedADEQUATE

exact p valuesADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedADEQUATE

assumptions verifiedADEQUATE

mathematical plausibilityPASS

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

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

Evidence

“Differences between the two groups were tested using linear mixed effects models for continuous variables and generalised linear mixed effects models for categorical variables.”

Statistical analysisFind in source

“with a difference of −1.88% (−2.57% to −1.19%, P<0.001) at 12 months”

ResultsFind in source

PASSReviewer 2· 90% conf

Statistical methods are appropriate and well-described, with exact p-values and confidence intervals reported; no arithmetic errors detected.

Evidence

“Differences between the two groups were tested using linear mixed effects models for continuous variables and generalised linear mixed effects models for categorical variables.”

Statistical analysisFind in source

“with a difference of −1.88% (−2.57% to −1.19%, P<0.001) at 12 months”

ResultsFind in source

“All analyses were conducted using SAS 9.4 (SAS Institute, Cary, NC).”

Statistical analysisFind in source

The data availability statement says 'The data underlying the study findings are op...' (truncated) and mentions code in supplementary files, but no repository or accession numbers are provided. This is inadequate for a clinical trial.

Sub-criteria

code sharingINADEQUATE

accession numbersN/A

repository depositNOT REPORTED

data availability statementINADEQUATE

Per reviewer (2) — the votes behind the verdict

WARNReviewer 1· 80% conf

Data availability statement is vague; code is mentioned but not deposited in a public repository.

Evidence

“The data underlying the study findings are op”

Data availabilityFind in source

“The supplementary files include the code used to analyse the data in the study.”

Data availabilityFind in source

WARNReviewer 2· 80% conf

A data availability statement exists but is vague, stating data are available on request without a clear mechanism; code is mentioned in supplementary files.

Evidence

“The data underlying the study findings are op”

Data availabilityFind in source

“The supplementary files include the code used to analyse the data in the study.”

Data availabilityFind in source

Trial registered (NCT05645640). Reporting guideline not explicitly mentioned but the paper follows CONSORT-like structure. All outcomes reported including null results. Limitations discussed. Conclusions proportional. Funding and COI provided.

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineNOT REPORTED

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, funding, COI, and limitations discussed.

Evidence

“Trial registration ClinicalTrials.gov NCT05645640 .”

AbstractFind in source

“This study has several limitations. Firstly, group assignment was not concealed from the research staff.”

LimitationsFind in source

PASSReviewer 2· 90% conf

The paper is transparent with trial registration, detailed methods, discussion of limitations, and proportional conclusions.

Evidence

“Trial registration ClinicalTrials.gov NCT05645640 .”

AbstractFind in source

“This study has several limitations. Firstly, group assignment was not concealed from the research staff.”

LimitationsFind in source

“Funding: This trial was supported by the National High Level Hospital Clinical Research Funding (2022-GSP-GG-4), Chinese Academy of Medical Sciences Innovation Fund for Medical Science (2024-I2M-ZD-002; 2021-1-I2M-011), and 111 Project from the Ministry of Education of China ( B16005 ).”

FundingFind in source

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

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 34 references by DOI: 32 verified — 1 DOI unresolved, 1 no DOI (shown, not verified).

Copyediting

7 minor

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

No major wording or formatting errors. 7 minor suggestions below.

7 copyedit issues flagged: mostly typo, consistency, clarity.

Kaimen Rigor Action ItemsFinal pass before journal submission

The published paper is robust overall, but an informed reader should weigh the incomplete data availability statement and the one reference not found in the registry. A correction or erratum to complete the data availability statement and verify the missing reference would strengthen the paper's transparency.

1.
HIGHdata code
Complete the data availability statement in the Data availability statement section: specify a repository (e.g., a managed-access platform) with a DOI or accession number, or describe a clear data access committee procedure with conditions and timeframe.
The current statement is truncated and does not provide a verifiable access route, which is a reporting gap for a clinical trial.
2.
HIGHdata code
Deposit the analysis code in a public repository (e.g., GitHub, Zenodo) with a persistent identifier and reference it in the data availability statement.
Code mentioned only in supplementary files without a persistent identifier reduces reproducibility and transparency.
3.
HIGHreporting
Verify the reference not found in the registry: [Chinese guideline on the primary prevention of cardiovascular diseases] (doi:10.3760/cma.j.cn112148-20201009-00796) — correct the citation or provide a verifiable source.
A reference that cannot be located in any registry may be fabricated or contain an error; this is a potential integrity concern.
4.
MEDIUMreporting
Explicitly state adherence to a reporting guideline such as CONSORT in the Methods or a separate section.
Although the paper follows CONSORT-like structure, explicitly mentioning the guideline improves transparency and helps readers assess reporting completeness.
5.
MEDIUMethics
Add a statement about regulatory compliance (e.g., Declaration of Helsinki) in the Ethics statements section.
Regulatory compliance is implied but not explicitly stated, which is a minor gap in ethical reporting.
6.
MEDIUMreporting
Include a note on how outliers were handled in the Statistical analysis section.
Outlier handling is not explicitly described; adding this detail would improve methodological completeness.
7.
LOWcopyedit
In the Abstract, Results, add a space before the parenthesis: change '−1.88% (95% confidence interval (CI) −2.57% to −1.19%; P<0.001)' to '−1.88% (95% CI −2.57% to −1.19%; P<0.001)'.
Minor formatting inconsistency for cleaner presentation.
8.
LOWcopyedit
In the Abstract, Participants, change 'owned a smart phone' to 'owned a smartphone'.
Inconsistent hyphenation of 'smartphone'.
9.
LOWcopyedit
In the Results, Secondary outcomes, add a space after 'by': change 'decreased by−10.9 mm Hg' to 'decreased by −10.9 mm Hg'.
Missing space after 'by'.
10.
LOWcopyedit
In the Methods, Statistical analysis, rephrase 'The actual intracluster correlation coefficient was 0.06, with a statistical power of 88% achieved.' to 'The actual intracluster correlation coefficient was 0.06, and the achieved statistical power was 88%.'
Awkward phrasing.
11.
LOWcopyedit
Ensure consistent formatting of manufacturer details throughout (e.g., in Methods, Intervention group, the smart band details are in parentheses; check other instances).
Consistency in formatting improves readability.
12.
LOWcopyedit
In Table 2, ensure the footnote marker for '† Lifetime risk of ASCVD could not be calculated using the China-PAR model in one participant owing to age (>85 years).' is correctly placed in the table.
Check footnote placement for clarity.

Full text (50,101 chars)Analyzed: Aug 15, 2026

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A village doctor-led mobile health intervention for cardiovascular risk reduction in rural China: cluster randomised controlled trial.

Zhang X, Wang S, Zhou X, Tang Y, Xing L, Ma S, Xu Y, Wu C, Cui J, Yang Y, Lin C, Wu Y, Zhang H, Fan L, Xu C, Li X, SMARTER Collaborative Group

Read full text (PMC)

DOI

10.1136/bmj-2024-082765

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Record fingerprint

dab5f98e7210209323352d0e508fe4012e371baef78cc8916d42e3f213b44f4b

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 / 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★
ClaimsTreatment effect not shown to be clinically meaningful−0.5★
ReportingData & code availability partially met−0.25★
CitationsUnresolved reference−0.25★

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

Not verified in this report

No data or code availability links were detected to verify.

Biggest issues

01Efficacy rests on an unvalidated surrogate endpoint
highOverreachreviewer-assessedFull detail
The primary outcome is the change in predicted 10-year ASCVD risk using the China-PAR model, which is a surrogate for clinical cardiovascular events. The paper does not provide evidence linking this surrogate to hard clinical outcomes, nor does it demonstrate target engagement at the tested dose (the intervention is behavioral, not a drug). The efficacy claim rests on this surrogate without validation of its clinical meaningfulness.
“The primary outcome was mean change in 10 year risk of ASCVD based on the China-PAR model from baseline to the 12 month visit”
Find in source
02Treatment effect not shown to be clinically meaningful
highOverreachreviewer-assessedFull detail
The primary effect is a 1.88% absolute reduction in predicted 10-year ASCVD risk, which is a small fraction of the baseline risk (18.0% to 11.7% in intervention vs 17.8% to 13.6% in control). The paper does not anchor this to a minimal clinically important difference or demonstrate that this reduction translates into meaningful clinical benefit. The effect size is presented as statistically significant but lacks clinical meaningfulness.
“absolute difference −1.88% (95% confidence interval (CI) −2.57% to −1.19%; P<0.001)”
Find in source

Findings by category

Numerical inconsistencies

1 finding · worst low

Internal contradictions in the reported numbersAssessed

Recomputed 10 tests: 10 consistent, 0 inconsistent; 1 recomputed directly from the reported test statistics, 9 via agent-written checks.

Overstated conclusions

3 findings · worst high

Efficacy rests on an unvalidated surrogate endpointAssessed
Treatment effect not shown to be clinically meaningfulAssessed
Conclusions only partially backed by the presented evidenceAssessed

4 major claims checked against the paper's own evidence: 1 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; effect size not shown to be clinically meaningful.

Data authenticity concerns

2 findings · worst low

Data look implausibly cleanAssessed
Other integrity concernAssessed

3 integrity concerns flagged (0 high).

Reporting gaps

1 finding · worst medium

Data/code availability incompleteAssessed

Eight Dimensions7 pass · 1 warn

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 adequate citation of prior work and a logical rationale for the study.

Evidence

Introduction ¶1Find in source

“To meet practical needs and fill knowledge gaps, we developed a village doctor-led health management strategy featuring scalable tools based on mHealth technologies.”

Introduction ¶2Find in source

PASSReviewer 2· 90% conf

Evidence

Introduction ¶1Find in source

“To meet practical needs and fill knowledge gaps, we developed a village doctor-led health management strategy featuring scalable tools based on mHealth technologies.”

Introduction ¶2Find in source

paraphrase[Introduction, paragraph 2]

“Paraphrase: The study aims to fill the gap by involving village doctors and using a cluster randomised design.”

Sub-criteria

controlsADEQUATE

power analysisADEQUATE

blinding levelsADEQUATE

outlier handlingINADEQUATE

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 cluster randomised design is rigorous with adequate randomization, blinding of statisticians, power analysis, and pre-specified inclusion/exclusion criteria.

Evidence

“Overall, 127 villages (clusters), stratified by counties, were randomly assigned (1:1) to either the intervention group or the control group using a central randomisation system.”

MethodsFind in source

“Allocation was, however, concealed from the study statisticians.”

MethodsFind in source

Statistical analysisFind in source

PASSReviewer 2· 95% conf

The study design is rigorous with clear randomization, allocation concealment from statisticians, a priori sample size calculation, and pre-specified inclusion/exclusion criteria.

Evidence

“Overall, 127 villages (clusters), stratified by counties, were randomly assigned (1:1) to either the intervention group or the control group using a central randomisation system.”

MethodsFind in source

“The minimum sample size of 4200 participants in 120 villages (60 villages in each comparison group, and 35 participants in each village) was calculated for the primary outcome.”

Statistical analysisFind in source

MethodsFind 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

“The mean age of participants was 57.7 (SD 8.2) years, 2282 (50.3%) were women”

ResultsFind in source

PASSReviewer 2· 90% conf

Biological variables are well reported for a human trial, including sex, age, and health status; demographics are comprehensive.

Evidence

“The mean age of participants was 57.7 (SD 8.2) years, 2282 (50.3%) were women”

ResultsFind in source

“At baseline, mean systolic and diastolic blood pressure was 157.4 (SD 16.2) mm Hg and 93.0 (SD 10.9) mm Hg, respectively, fasting blood glucose level was 7.1 (SD 2.6) mmol/L”

ResultsFind in source

paraphrase[Table 1]

“Education: Primary school or lower 1881 (41.5) | Middle school 1696 (37.4) | High school 681 (15.0) | College or higher 275 (6.1)”

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 adequately reported.

Evidence

“This trial was approved (approval No 2022-1781) by the central ethics committee at Fuwai Hospital, Beijing, China.”

EthicsFind in source

“Written informed consent was obtained from all participants before inclusion.”

MethodsFind in source

PASSReviewer 2· 95% conf

Ethical approval is explicitly stated with a named ethics committee and approval number, and informed consent was obtained.

Evidence

“This trial was approved (approval No 2022-1781) by the central ethics committee at Fuwai Hospital, Beijing, China.”

EthicsFind in source

“Written informed consent was obtained from all participants before inclusion.”

MethodsFind in source

absence[Ethics statements]

Regulatory compliance is not explicitly named.

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 product (smart band) and software are identified; other bench resources are not applicable.

Evidence

“Each participant in the intervention group received a smart band (Huawei Band 4; Huawei Technologies, Dongguan, China).”

MethodsFind in source

“All analyses were conducted using SAS 9.4 (SAS Institute, Cary, NC).”

Statistical analysisFind in source

PASSReviewer 2· 85% conf

The investigational product (smart band) and software (SAS) are identified; no other biological/chemical resources are applicable.

Evidence

“Each participant in the intervention group received a smart band (Huawei Band 4; Huawei Technologies, Dongguan, China).”

MethodsFind in source

“All analyses were conducted using SAS 9.4 (SAS Institute, Cary, NC).”

Statistical analysisFind in source

Sub-criteria

tests namedADEQUATE

exact p valuesADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedADEQUATE

assumptions verifiedADEQUATE

mathematical plausibilityPASS

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

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

Evidence

“Differences between the two groups were tested using linear mixed effects models for continuous variables and generalised linear mixed effects models for categorical variables.”

Statistical analysisFind in source

“with a difference of −1.88% (−2.57% to −1.19%, P<0.001) at 12 months”

ResultsFind in source

PASSReviewer 2· 90% conf

Statistical methods are appropriate and well-described, with exact p-values and confidence intervals reported; no arithmetic errors detected.

Evidence

“Differences between the two groups were tested using linear mixed effects models for continuous variables and generalised linear mixed effects models for categorical variables.”

Statistical analysisFind in source

“with a difference of −1.88% (−2.57% to −1.19%, P<0.001) at 12 months”

ResultsFind in source

“All analyses were conducted using SAS 9.4 (SAS Institute, Cary, NC).”

Statistical analysisFind in source

Sub-criteria

code sharingINADEQUATE

accession numbersN/A

repository depositNOT REPORTED

data availability statementINADEQUATE

Per reviewer (2) — the votes behind the verdict

WARNReviewer 1· 80% conf

Data availability statement is vague; code is mentioned but not deposited in a public repository.

Evidence

“The data underlying the study findings are op”

Data availabilityFind in source

“The supplementary files include the code used to analyse the data in the study.”

Data availabilityFind in source

WARNReviewer 2· 80% conf

A data availability statement exists but is vague, stating data are available on request without a clear mechanism; code is mentioned in supplementary files.

Evidence

“The data underlying the study findings are op”

Data availabilityFind in source

“The supplementary files include the code used to analyse the data in the study.”

Data availabilityFind in source

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineNOT REPORTED

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, funding, COI, and limitations discussed.

Evidence

“Trial registration ClinicalTrials.gov NCT05645640 .”

AbstractFind in source

“This study has several limitations. Firstly, group assignment was not concealed from the research staff.”

LimitationsFind in source

PASSReviewer 2· 90% conf

The paper is transparent with trial registration, detailed methods, discussion of limitations, and proportional conclusions.

Evidence

“Trial registration ClinicalTrials.gov NCT05645640 .”

AbstractFind in source

“This study has several limitations. Firstly, group assignment was not concealed from the research staff.”

LimitationsFind in source

FundingFind in source

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

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 34 references by DOI: 32 verified — 1 DOI unresolved, 1 no DOI (shown, not verified).

Copyediting

7 minor

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

No major wording or formatting errors. 7 minor suggestions below.

7 copyedit issues flagged: mostly typo, consistency, clarity.

Kaimen Rigor Action ItemsFinal pass before journal submission

1.
HIGHdata code
Complete the data availability statement in the Data availability statement section: specify a repository (e.g., a managed-access platform) with a DOI or accession number, or describe a clear data access committee procedure with conditions and timeframe.
The current statement is truncated and does not provide a verifiable access route, which is a reporting gap for a clinical trial.
2.
HIGHdata code
Deposit the analysis code in a public repository (e.g., GitHub, Zenodo) with a persistent identifier and reference it in the data availability statement.
Code mentioned only in supplementary files without a persistent identifier reduces reproducibility and transparency.
3.
HIGHreporting
Verify the reference not found in the registry: [Chinese guideline on the primary prevention of cardiovascular diseases] (doi:10.3760/cma.j.cn112148-20201009-00796) — correct the citation or provide a verifiable source.
A reference that cannot be located in any registry may be fabricated or contain an error; this is a potential integrity concern.
4.
MEDIUMreporting
Explicitly state adherence to a reporting guideline such as CONSORT in the Methods or a separate section.
Although the paper follows CONSORT-like structure, explicitly mentioning the guideline improves transparency and helps readers assess reporting completeness.
5.
MEDIUMethics
Add a statement about regulatory compliance (e.g., Declaration of Helsinki) in the Ethics statements section.
Regulatory compliance is implied but not explicitly stated, which is a minor gap in ethical reporting.
6.
MEDIUMreporting
Include a note on how outliers were handled in the Statistical analysis section.
Outlier handling is not explicitly described; adding this detail would improve methodological completeness.
7.
LOWcopyedit
In the Abstract, Results, add a space before the parenthesis: change '−1.88% (95% confidence interval (CI) −2.57% to −1.19%; P<0.001)' to '−1.88% (95% CI −2.57% to −1.19%; P<0.001)'.
Minor formatting inconsistency for cleaner presentation.
8.
LOWcopyedit
In the Abstract, Participants, change 'owned a smart phone' to 'owned a smartphone'.
Inconsistent hyphenation of 'smartphone'.
9.
LOWcopyedit
In the Results, Secondary outcomes, add a space after 'by': change 'decreased by−10.9 mm Hg' to 'decreased by −10.9 mm Hg'.
Missing space after 'by'.
10.
LOWcopyedit
In the Methods, Statistical analysis, rephrase 'The actual intracluster correlation coefficient was 0.06, with a statistical power of 88% achieved.' to 'The actual intracluster correlation coefficient was 0.06, and the achieved statistical power was 88%.'
Awkward phrasing.
11.
LOWcopyedit
Ensure consistent formatting of manufacturer details throughout (e.g., in Methods, Intervention group, the smart band details are in parentheses; check other instances).
Consistency in formatting improves readability.
12.
LOWcopyedit
In Table 2, ensure the footnote marker for '† Lifetime risk of ASCVD could not be calculated using the China-PAR model in one participant owing to age (>85 years).' is correctly placed in the table.
Check footnote placement for clarity.

Full text (50,101 chars)Analyzed: Aug 15, 2026