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Kaimen Rigor review

Telemedicine-supported lifestyle intervention for glycemic control in patients with CHD and T2DM: multicenter, randomized controlled trial.

Mueller S, Dinges SMT, Gass F, Fegers-Wustrow I, Treitschke J, von Korn P, Boscheri A, Krotz J, Freigang F, Dubois C, Winzer EB, Linke A, Edelmann F, Feuerstein A, Wolfram O, Schäfer K, Verket M, Wolfarth B, Dörr M, Wachter R, Hackenberg B, Rust S, Nebling T, Amelung V, Halle M

DOI: 10.1038/s41591-025-03498-w
Record issued: 2026-08-15
Engine: 7.39.0
Exported: 2026-09-22

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/e502f565-d910-45fc-84f6-f54c2ef38fa3 is authoritative.

Kaimen Rigor review

Kaimen Rigor reviewed

2.75 / 5

Weak — serious problems found

Interventional Study

Critical

High-priority

How this rating was calculated

Started at 5★ — deductions

IntegrityIntegrity concern ×2−1★
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 efficacy claim is based on change in HbA1c, a surrogate biomarker for glycemic control. The paper does not demonstrate target engagement at the tested dose (e.g., PK/PD) nor cite validated evidence linking HbA1c reduction to the specific clinical outcome of interest (major adverse cardiovascular events) in this population. The effect is modest and not sustained.
“The study met its primary endpoint of reduced glycated hemoglobin after 6 months in favor of the lifestyle intervention group (mean between-group difference in the complete-case analysis (n = 197 and n = 193), −0.13% (95% confidence interval, −0.25 to −0.01),…”
Find in source
02Treatment effect not shown to be clinically meaningful
highOverreachreviewer-assessedFull detail
The primary effect size is a mean between-group difference in HbA1c of -0.13% at 6 months, which is small and below the commonly accepted minimal clinically important difference of 0.3-0.5% for HbA1c. The paper itself describes the effect as 'modest' and notes that it was not consistent after multiple imputation. No anchor to clinical meaningfulness is provided for the primary endpoint.
“In conclusion, a home-based lifestyle intervention with telemedicine support showed modest effects in patients with CHD and T2DM.”
Find in source

Findings by category

101ArithmeticNumerical inconsistencies 302OverreachOverstated conclusions 03AuthenticityNone found 104DisclosureReporting gaps 05AvailabilityNone found 06Copyedit5 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 multicenter RCT with rigorous randomization, pre-specified analyses, and transparent reporting. The main weakness is the vague data availability statement, and there are minor copyedit issues including a potential percentage inconsistency in Table 1.

Both reviewers classified the study as interventional (RCT), and no divergence was present. The evaluation covered the full text, including methods, results, and discussion. Non-applicable sub-criteria (e.g., animal housing, cell lines) were excluded. The statistics verification covered only 4 tests; the remaining statistics 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 4 tests: 4 consistent, 0 inconsistent; 4 via agent-written checks.

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

CONSISTENTreported p = .040 · recomputed p = .034Reviewer 1
Primary endpoint between-group difference in HbA1c change at 6 months (complete-case analysis).
“mean between-group difference in the complete-case analysis ( n = 197 and n = 193), −0.13% (95% confidence interval, −0.25 to −0.01), P = 0.04”
Find in source
Taken as given: The reported difference is the mean between-group difference.; The 95% CI is two-sided.; The p-value is two-sided.
Method: Recomputed p-value from the reported estimate and 95% CI using the normal approximation.
How we recomputed it: pCI(-0.13, -0.25, -0.01, 0)
CONSISTENTreported p < .001 · recomputed p = <.001Reviewers 1, 2
Between-group difference in body weight change at 6 months.
“difference in mean changes = −1.4 kg (−2.1 to −0.8), P < 0.001”
Find in source
Taken as given: The reported difference is the mean between-group difference.; The 95% CI is two-sided.; The p-value is two-sided.
Method: Recomputed p-value from the reported estimate and 95% CI using the normal approximation.
How we recomputed it: pCI(-1.4, -2.1, -0.8, 0)
CONSISTENTreported p = .006 · recomputed p = .005Reviewer 1
Between-group difference in SF-36 mental component score at 6 months.
“changes in the QoL mental component score (2.7 (0.8–4.6), P = 0.006)”
Find in source
Taken as given: The reported difference is the mean between-group difference.; The 95% CI is two-sided.; The p-value is two-sided.
Method: Recomputed p-value from the reported estimate and 95% CI using the normal approximation.
How we recomputed it: pCI(2.7, 0.8, 4.6, 0)
CONSISTENTreported p = .040 · recomputed p = .040Reviewer 2
Primary endpoint between-group difference in HbA1c change at 6 months (t-test).
“difference in mean changes, −0.13% (95% CI, −0.25 to −0.01%), P = 0.04”
Find in source
Taken as given: The t-statistic is approximately 2.06 (derived from the CI and n=390).; Degrees of freedom = 390 - 2 = 388.
Method: Two-tailed t-test p-value from t-statistic and df.
How we recomputed it: pT(2.06, 388)

lowinternal contradiction
In Table 1, the 'Handling of technical devices' row for usual care shows percentages that do not sum to 100% (12.1+67.3+8.5=87.9), suggesting a possible data error.
Handling of technical devices | Rather easy | 47 (18.7%) | 30 (12.1%) | Rather difficult | 173 (68.9%) | 167 (67.3%) | Unknown | 15 (6.0%) | 29 (8.5%)
Table 1reviewer’s wording
lowinternal contradiction
In Table 1, the percentage for 'Unknown' in 'Handling of technical devices' for usual care is 8.5%, but 29/248 = 11.7%.
“Unknown | 15 (6.0%) | 29 (8.5%)”
Table 1Find in source

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

7 major claims checked against the paper's own evidence: 2 only partially supported (evidence backs part of the claim; gaps or caveats remain); the rest adequately supported.

partialReviewer 1
The intervention was not associated with an increased risk of MACE.
The difference in MACE was not statistically significant, but the numerical imbalance (20 vs 11) and the authors' own discussion of potential mechanisms warrant caution.
Evidence: 31 patients (6.2%) had a MACE (lifestyle intervention, n = 20 (8.0%); usual care, n = 11 (4.4%); P = 0.15).
“At 12 months, 31 patients (6.2%) had a major adverse cardiovascular event (lifestyle intervention, n = 20 (8.0%); usual care, n = 11 (4.4%); P = 0.15)”
AbstractFind in source
partialReviewer 2
The higher number of MACE in the intervention group was unlikely to be causally related to the intervention.
The paper provides indirect evidence (most events in non-adherent patients) but cannot rule out causality; the claim is somewhat speculative.
Evidence: Most MACE occurred in non-adherent patients; no serious adverse events during exercise.
“Although we observed a numerically higher number of 4P-MACE in the lifestyle intervention group (20 versus 11 events), it is unlikely that this difference was causally related to the exercise intervention, because most events occurred in patients who were nonadherent to the exercise intervention.”
Discussion ¶6Find in source
supportedReviewers 1, 2
The telemedicine-supported lifestyle intervention reduced HbA1c after 6 months compared to usual care.
The primary endpoint analysis shows a statistically significant difference in the complete-case analysis, supporting the claim.
Evidence: Primary endpoint: difference in mean changes −0.13% (95% CI −0.25 to −0.01), P = 0.04.
“The study met its primary endpoint of reduced glycated hemoglobin after 6 months in favor of the lifestyle intervention group (mean between-group difference in the complete-case analysis ( n = 197 and n = 193), −0.13% (95% confidence interval, −0.25 to −0.01), P = 0.04).”
AbstractFind in source
supportedReviewers 1, 2
No statistically significant between-group differences were observed at 12 months.
The 12-month analysis shows no significant differences, consistent with the claim.
Evidence: At 12 months, difference in HbA1c change = −0.01% (95% CI −0.16 to 0.14), P = 0.90.
“When individualized feedback and health literacy training were discontinued after 6 months (while other telemedicine tools were maintained), no statistically significant between-group differences were observed at 12 months.”
AbstractFind in source
supportedReviewers 1, 2
The intervention improved body weight, mental QoL, cognitive restraint, and health literacy at 6 months.
These secondary endpoints showed statistically significant differences, supporting the claim.
Evidence: Body weight: −1.4 kg (95% CI −2.1 to −0.8), P < 0.001; MCS: 2.7 (0.8–4.6), P = 0.006; cognitive restraint: 1.1 (0.3–1.8), P = 0.005; health literacy: 0.6 (0.0–1.2), P = 0.04.
At 6 months, weight loss was significantly higher following lifestyle intervention compared with usual care (difference in mean changes = −1.4 kg (−2.1 to −0.8), P < 0.001). Furthermore, changes in the QoL mental component score (2.7 (0.8–4.6), P = 0.006), the eating behavior score for ‘cognitive restraint of eating’ (1.1 (0.3–1.8), P = 0.005) and health literacy (0.6 (0.0–1.2), P = 0.04) were significantly different between groups.
Resultsreviewer’s wording
supportedReviewer 1
The intervention is difficult to implement and has minor clinical effects in this population.
The modest effect size, low adherence, and lack of sustained benefit support this conclusion.
Evidence: Only 41% fulfilled exercise adherence criteria; effects were not sustained at 12 months.
“In conclusion, an exclusively home-based lifestyle intervention program with telemedicine support and individualized remote counseling is difficult to implement and has minor beneficial clinical effects in older patients with CHD and a long history of T2DM.”
DiscussionFind in source
supportedReviewer 2
The intervention had modest effects in patients with CHD and T2DM.
The effect size is small (0.13% HbA1c reduction) and not consistent across sensitivity analyses, supporting the 'modest' characterization.
Evidence: Primary endpoint effect size is small; multiple imputation analysis showed no significant difference.
“In conclusion, a home-based lifestyle intervention with telemedicine support showed modest effects in patients with CHD and T2DM.”
AbstractFind in source

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

INADEQUATESurrogate endpoint
The primary efficacy claim is based on change in HbA1c, a surrogate biomarker for glycemic control. The paper does not demonstrate target engagement at the tested dose (e.g., PK/PD) nor cite validated evidence linking HbA1c reduction to the specific clinical outcome of interest (major adverse cardiovascular events) in this population. The effect is modest and not sustained.
“The study met its primary endpoint of reduced glycated hemoglobin after 6 months in favor of the lifestyle intervention group (mean between-group difference in the complete-case analysis (n = 197 and n = 193), −0.13% (95% confidence interval, −0.25 to −0.01), P = 0.04).”
Find in source
INADEQUATEEffect size
The primary effect size is a mean between-group difference in HbA1c of -0.13% at 6 months, which is small and below the commonly accepted minimal clinically important difference of 0.3-0.5% for HbA1c. The paper itself describes the effect as 'modest' and notes that it was not consistent after multiple imputation. No anchor to clinical meaningfulness is provided for the primary endpoint.
“In conclusion, a home-based lifestyle intervention with telemedicine support showed modest effects in patients with CHD and T2DM.”
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 multiple prior studies and meta-analyses on lifestyle interventions in CHD and T2DM, acknowledges the limited evidence in combined conditions, and clearly states the hypothesis. Limitations of prior research (e.g., transient effects, low adherence) are explicitly discussed and addressed by the telemedicine-supported design.

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 rationale linking the intervention to the study objectives.

Evidence

paraphrase[Introduction, paragraph 1-3]

“However, despite evidence of physical activity interventions in patients with standalone conditions, only three trials to date have investigated the effects of exercise training compared to a control group in patients with both conditions. These trials did not show significant group differences in changes of HbA1c.”

paraphrase[Introduction, paragraph 4]

“Telemedicine-supported home-based approaches have emerged as a potentially effective and cost-efficient alternative, also reaching patients who may not be able to take part in supervised on-site programs.”

paraphrase[Introduction, paragraph 5]

PASSReviewer 2· 90% conf

The paper establishes a clear scientific premise with extensive prior work and a logical rationale linking the intervention to the study objectives.

Evidence

paraphrase[Introduction, paragraph 1-3]

“We hypothesized that 6 months of individualized, telemedicine-supported, home-based exercise training and nutritional counseling with regular feedback via telephone and e-mail, as well as health literacy education, will significantly reduce HbA1c compared to usual care and that these improvements can be maintained over an additional 6 months without regular feedback and health literacy education.”

IntroductionFind in source

“As supervised lifestyle intervention programs are resource-intensive for caregivers and patients alike, and home-based interventions often reveal the disadvantage of low adherence rates, neither type of intervention seems to be sustainable in the long term.”

Introduction ¶3Find in source

Randomization was performed using a web-based system stratified by study site with block sizes of four. The paper states that patients and staff were not blinded, but adverse event forms were reviewed by a physician blinded to treatment group. A sample size calculation was performed, though the target was not met due to COVID-19. Inclusion/exclusion criteria are detailed. Missing data handling (multiple imputation) and per-protocol analyses are pre-specified.

Sub-criteria

controlsN/A

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· 90% conf

The trial design is rigorous with adequate randomization, blinding of outcome assessors, a priori sample size calculation, and pre-specified inclusion/exclusion criteria.

Evidence

“Eligible patients were randomly assigned (1:1) to lifestyle intervention or usual care using a web-based system (secuTrial, interActive Systems GmbH) stratified by study site with block sizes of four.”

MethodsFind in source

“Each adverse event form was reviewed by one physician blinded to treatment group assignment.”

MethodsFind in source

paraphrase[Methods, Sample size calculation]

“With a power of 80%, a two-sided significance level of α = 0.05 and an estimated dropout rate of 15%, a total of 750 patients would have been required to detect a significant difference in the primary endpoint.”

PASSReviewer 2· 90% conf

The trial design is rigorous with adequate randomization, blinding of outcome assessors, a priori power analysis, and pre-specified inclusion/exclusion criteria.

Evidence

MethodsFind in source

“Each adverse event form was reviewed by one physician blinded to treatment group assignment.”

MethodsFind in source

paraphrase[Methods, Sample size calculation]

The paper reports sex (84% men), age (mean 68 years), and health status (HbA1c, BMI, comorbidities) in Table 1. Since both sexes are enrolled, sex_justified is not applicable. Demographics are adequately reported.

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

“68 ± 8 years; 84% men”

AbstractFind in source

paraphrase[Table 1]

“Sex | Male | 208 (82.9%) | 210 (84.7%) | | Female | 43 (17.1%) | 38 (15.3%)”

PASSReviewer 2· 90% conf

Biological variables and demographics are well reported, including sex, age, health status, and detailed baseline characteristics.

Evidence

“502 patients with combined CHD and T2DM (68 ± 8 years; 84% men)”

AbstractFind in source

paraphrase[Results, Patient disposition]

“Demographic and clinical characteristics at baseline (16% female; mean age = 68 years (s.d., 8 years); 98% white; mean HbA1c = 6.9% (s.d., 0.9%)) are shown in Table.”

The paper states approval by the ethics committee of the Technical University of Munich (reference 144/18 S) and other local ethics committees. Written informed consent was obtained from all participants. Regulatory compliance is implied by adherence to ethical standards.

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

Ethics approval from named committees and informed consent are clearly documented.

Evidence

“The original study protocol was approved by the ethics committee of the Technical University of Munich on 7 May 2018 (reference: 144/18 S) and the local ethics committees at the Universities of Berlin, Aachen, Magdeburg, Dresden, Leipzig, Greifswald and Freiburg, and the ethics committees of the Medical Associations of Hesse and Baden-Württemberg.”

EthicsFind in source

“All participants provided written informed consent.”

EthicsFind in source

PASSReviewer 2· 95% conf

Ethical approvals and informed consent are clearly documented with named ethics committees and protocol numbers.

Evidence

EthicsFind in source

“All participants provided written informed consent.”

EthicsFind in source

The intervention is described in detail: exercise training, nutritional counseling, and health literacy training. The smartphone application (LeIKD app) and devices (Polar H7, Beurer pedometer, glucose meter) are named with manufacturers. Software tools (secuTrial, R) are identified. Since this is a behavioral intervention, bench resources are not applicable.

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 (the lifestyle intervention) and its components are adequately described, including the smartphone application and devices.

Evidence

paraphrase[Methods, Interventions]

“Each patient who was randomized to the lifestyle intervention group received an individualized exercise schedule including endurance (primarily walking and/or cycling, depending on patient preference) and strength training with the aim to progressively increase training duration to ≥150 min per week.”

“All statistical tests were performed using R Statistical Software (v.4.0.2, R Foundation for Statistical Computing)”

Statistical analysisFind in source

PASSReviewer 2· 85% conf

Key resources, including the investigational intervention components and software, are adequately identified.

Evidence

“All statistical tests were performed using R Statistical Software (v.4.0.2, R Foundation for Statistical Computing)”

Statistical analysisFind in source

paraphrase[Methods, Interventions]

The paper names the tests used (t-tests, chi-square test) and reports exact p-values (e.g., P = 0.04) and confidence intervals. Effect sizes are reported with CIs. Software is identified. Data presentation includes per-group n and dispersion. Mathematical plausibility checks were not performed due to continuous outcomes and large N.

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· 85% conf

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

Evidence

“All endpoints except for the number of patients with 4P-MACE were evaluated with t tests for independent samples, whereas the number of patients with 4P-MACE was evaluated with the χ 2 test.”

Statistical analysisFind in source

paraphrase[Abstract]

“P = 0.04”

“mean between-group difference in the complete-case analysis ( n = 197 and n = 193), −0.13% (95% confidence interval, −0.25 to −0.01)”

AbstractFind in source

PASSReviewer 2· 85% conf

Statistical methods are appropriate and well-reported, with exact p-values, effect sizes with CIs, and software identified.

Evidence

“All endpoints except for the number of patients with 4P-MACE were evaluated with t tests for independent samples, whereas the number of patients with 4P-MACE was evaluated with the χ 2 test.”

Statistical analysisFind in source

“difference in mean changes, −0.13% (95% CI, −0.25 to −0.01%), P = 0.04”

ResultsFind in source

The data availability statement says aggregated data may be shared upon request to the corresponding author after consultation with data protection officers and signing a data sharing agreement. This is a managed-access route but lacks a named platform or committee, making it reported_but_inadequate. No code is shared, but the study is a clinical trial, so code sharing is not applicable.

Sub-criteria

code sharingN/A

accession numbersN/A

repository depositN/A

data availability statementINADEQUATE

Per reviewer (2) — the votes behind the verdict

WARNReviewer 1· 90% conf

A data availability statement is present but vague, offering only 'on request' without a concrete mechanism or platform.

Evidence

paraphrase[Data availability]

“However, upon request to the corresponding author (M.H.), aggregated data ... may be shared after consultation with the data protection officers and legal representatives of the participating institutions and after signing a data sharing agreement.”

WARNReviewer 2· 80% conf

A data availability statement is present but vague, offering only 'on request' without a concrete mechanism or platform.

Evidence

paraphrase[Data availability]

The trial is registered (NCT03835923). Methods are detailed enough for replication. Limitations are thoroughly discussed, including COVID-19 impact, low adherence, and lack of blinding. Conclusions are appropriately cautious. Funding and competing interests are declared.

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineINADEQUATE

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 detailed methods, trial registration, discussion of limitations, and proportional conclusions.

Evidence

“ClinicalTrials.gov registration: NCT03835923”

AbstractFind in source

“The present study has several limitations. Foremost, the COVID-19 pandemic had a significant influence on the original study design impairing patient recruitment, forcing intermediate closures of study sites and sports facilities and other legal restrictions.”

Discussion ¶8Find in source

“This study was funded by the Federal Joint Committee (Innovationsfonds des Gemeinsamen Bundesausschusses; reference 01NVF17015 (to B.H., V.A. and M.H.)).”

AcknowledgementsFind in source

PASSReviewer 2· 90% conf

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

Evidence

“ClinicalTrials.gov registration: NCT03835923”

AbstractFind in source

Discussion ¶8Find in source

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

ClinicalTrials.gov

NCT03835923

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 48 references by DOI: 1 verified — 47 no DOI (shown, not verified).

NO DOI
The global burden of cardiovascular diseases and risk: a compass for future health
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Diabetes, metformin and glucose lowering therapies after myocardial infarction: Insights from the SWEDEHEART registry
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
The burden of diabetes mellitus in patients with coronary heart disease: a methodological approach to assess quality-adjusted life-years based on individual-level longitudinal survey data
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
2019 ESC guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
2023 ESC guidelines for the management of cardiovascular disease in patients with diabetes: developed by the task force on the management of cardiovascular disease in patients with diabetes of the European Society of Cardiology (ESC)
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Clinical management of stable coronary artery disease in patients with type 2 diabetes mellitus: a scientific statement from the American Heart Association
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
The prognostic importance of weight loss in coronary artery disease: a systematic review and meta-analysis
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Exercise-based cardiac rehabilitation for coronary heart disease: a meta-analysis
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Physical activity advice only or structured exercise training and association with HbA 1c levels in type 2 diabetes: a systematic review and meta-analysis
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Improving type 2 diabetes mellitus glycaemic control through lifestyle modification implementing diet intervention: a systematic review and meta-analysis
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Cardiovascular effects of intensive lifestyle intervention in type 2 diabetes
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Impact of an intensive lifestyle intervention on use and cost of medical services among overweight and obese adults with type 2 diabetes: the action for health in diabetes
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
2019 ESC guidelines for the diagnosis and management of chronic coronary syndromes: the task force for the diagnosis and management of chronic coronary syndromes of the European Society of Cardiology (ESC)
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Long- but not short-term multifactorial intervention with focus on exercise training improves coronary endothelial dysfunction in diabetes mellitus type 2 and coronary artery disease
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Effects of exercise training on HbA 1c and VO 2 peak in patients with type 2 diabetes and coronary artery disease: a randomised clinical trial
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Effects of physical activity and exercise training on cardiovascular risk in coronary artery disease patients with and without type 2 diabetes
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
The future is now: a call for action for cardiac telerehabilitation in the COVID-19 pandemic from the secondary prevention and rehabilitation section of the European Association of Preventive Cardiology
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Telehealth interventions for the secondary prevention of coronary heart disease: a systematic review and meta-analysis
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Clinician approach to cardiopulmonary exercise testing for exercise prescription in patients at risk of and with cardiovascular disease
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Exercise training for patients with type 2 diabetes and cardiovascular disease: what to pursue and how to do it. A position paper of the European Association of Preventive Cardiology (EAPC)
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Impact of different training modalities on glycaemic control and blood lipids in patients with type 2 diabetes: a systematic review and network meta-analysis
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
The impact of automated brief messages promoting lifestyle changes delivered via mobile devices to people with type 2 diabetes: a systematic literature review and meta-analysis of controlled trials
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Mobile phone text messaging in improving glycaemic control for patients with type 2 diabetes mellitus: a systematic review and meta-analysis
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Assessing the impact of telemonitoring-facilitated lifestyle modifications on diabetes outcomes: a systematic review and meta-analysis
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Effectiveness of telemedicine for reducing cardiovascular risk: a systematic review and meta-analysis
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Effects of mobile text messaging on glycemic control in patients with coronary heart disease and diabetes mellitus
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
2021 ESC guidelines on cardiovascular disease prevention in clinical practice
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Association of an intensive lifestyle intervention with remission of type 2 diabetes
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Screening for glucose perturbations and risk factor management in dysglycemic patients with coronary artery disease—a persistent challenge in need of substantial improvement: a report from ESC EORP EUROASPIRE V
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Cardiovascular risk factors, exercise capacity and health literacy in patients with chronic ischaemic heart disease and type 2 diabetes mellitus in Germany: baseline characteristics of the lifestyle intervention in chronic ischaemic heart disease and type 2 diabetes study
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
2016 European guidelines on cardiovascular disease prevention in clinical practice: the sixth joint task force of the European Society of Cardiology and other societies on cardiovascular disease prevention in clinical practice (constituted by representatives of 10 societies and by invited experts) developed with the special contribution of the European Association for Cardiovascular Prevention & Rehabilitation (EACPR)
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Telemedicine acceptance and efficacy in the context of preventive cardiology interventions: a systematic review
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Cardiovascular effects of weight loss in old adults with overweight/obesity according to change in skeletal muscle mass
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Women’s participation in cardiovascular clinical trials from 2010 to 2017
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
The Study of Health in Pomerania (SHIP) reference values for cardiopulmonary exercise testing
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Lifestyle intervention in chronic ischaemic heart disease and type 2 diabetes (the LeIKD study): study protocol of a prospective, multicentre, randomised, controlled trial
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Interval endurance and resistance training as part of a community-based secondary prevention program for patients with diabetes mellitus and coronary artery disease
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
High-intensity interval training in patients with heart failure with reduced ejection fraction
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Effect of high-intensity interval training, moderate continuous training, or guideline-based physical activity advice on peak oxygen consumption in patients with heart failure with preserved ejection fraction: a randomized clinical trial
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Combined endurance and resistance exercise training in heart failure with preserved ejection fraction: a randomized controlled trial
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
ACSM’s Guidelines for Exercise Testing and Prescription
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Long-term effects of a psychological group intervention on physical exercise and health: the MoVo concept
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Successful weight loss and maintenance in everyday clinical practice with an individually tailored change of eating habits on the basis of food energy density
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
The behavior change technique taxonomy (v1) of 93 hierarchically clustered techniques: building an international consensus for the reporting of behavior change interventions
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Behavior change techniques and the effects associated with digital behavior change interventions in sedentary behavior in the clinical population: a systematic review
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Biophysiologic outcomes of the enhancing adherence in type 2 diabetes (ENHANCE) trial
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
mice: multivariate imputation by chained equations in R
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/NCT03835923LIVEHTTP 200
Resolves, but the content could not be matched to the paper.

Copyediting

5 minor

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

No major wording or formatting errors. 5 minor suggestions below.

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

MINORconsistencyTable 1, 'Handling of technical devices' row
“Unknown | 15 (6.0%) | 29 (8.5%)”
→ Check the percentage for usual care: 29/248 = 11.7%, not 8.5%.
The percentage appears inconsistent with the count and group total.
MINORtypoMethods, Examinations and endpoints
“TEFQ”
→ Change to TFEQ for consistency with the abbreviation used elsewhere.
Inconsistent abbreviation for Three-Factor Eating Questionnaire.
MINORclarityAbstract
“The study met its primary endpoint of reduced glycated hemoglobin after 6 months in favor of the lifestyle intervention group”
→ Consider clarifying that the primary endpoint was the change in HbA1c, not 'reduced glycated hemoglobin'.
Slight ambiguity in phrasing.
MINORconsistencyTable 1, 'Handling of technical devices' row
“Unknown | 15 (6.0%) | 29 (8.5%)”
→ Check if the percentage for usual care (8.5%) is correct; it may be a typo for 11.7% based on the sum of other categories.
The percentages in the 'Handling of technical devices' row do not sum to 100% for the usual care group (12.1+67.3+8.5=87.9), suggesting a possible error.
MINORtypoMethods, Examinations and endpoints
“TEFQ”
→ Change to TFEQ (Three-Factor Eating Questionnaire) for consistency.
The abbreviation TEFQ is used inconsistently; elsewhere it is TFEQ.

Kaimen Rigor Action ItemsFinal pass before journal submission

The published work is robust overall, but an informed reader should weigh the vague data availability statement and the minor Table 1 percentage inconsistency. These do not invalidate the conclusions but warrant a correction or clarification from the authors.

1.
HIGHdata code
In the Data availability section, specify a concrete data access mechanism, such as a named data access committee or a platform like Vivli, and provide a timeline for response.
The current 'on request' statement is vague and does not meet transparency standards for a clinical trial.
2.
HIGHreporting
In Table 1, 'Handling of technical devices' row, correct the percentage for usual care 'Unknown' from 8.5% to 11.7% (29/248) and ensure all percentages sum to 100%.
The current percentage is internally inconsistent and could be seen as a data error.
3.
MEDIUMcopyedit
In Methods, Examinations and endpoints, change 'TEFQ' to 'TFEQ' for consistency with the abbreviation used elsewhere.
Inconsistent abbreviation for the Three-Factor Eating Questionnaire may confuse readers.
4.
MEDIUMreporting
In the Reporting summary, explicitly state adherence to CONSORT guidelines and provide the checklist as supplementary material.
Reviewer 1 flagged the reporting guideline as inadequate; explicit CONSORT adherence strengthens transparency.
5.
MEDIUMdata code
Consider depositing the statistical analysis code (e.g., R scripts for imputation and analysis) in a public repository like Zenodo with a DOI.
Sharing code enhances reproducibility, though not strictly required for a clinical trial.
6.
MEDIUMreporting
In the Abstract, clarify that the primary endpoint was the change in HbA1c, not 'reduced glycated hemoglobin'.
The current phrasing is slightly ambiguous and could be misinterpreted.
7.
MEDIUMethics
In the Ethics approval section, explicitly state adherence to the Declaration of Helsinki or another recognized ethical framework.
Reviewer 2 noted regulatory compliance is implied but not explicitly named; adding this strengthens the ethics reporting.
8.
MEDIUMstatistics
In the Methods, clarify the handling of missing data for secondary endpoints and whether multiple imputation was applied to them.
Reviewer 1 suggested this to improve completeness of the statistical methods.
9.
MEDIUMstatistics
In the Discussion, explicitly address the potential for type I error due to multiple comparisons, even though CIs were not adjusted.
Preempts criticism about multiple testing in secondary endpoints.
10.
LOWreporting
In the Results, report the number of patients with missing data for each secondary endpoint in the tables.
Improves transparency about missingness beyond the primary endpoint.
11.
LOWdata code
In the Data availability statement, clarify whether the aggregated data include individual-level data or only summary statistics.
Sets expectations for potential reusers and clarifies the scope of sharing.
12.
LOWreporting
In the Methods, specify the version of the statistical analysis plan and how deviations were handled.
Strengthens adherence to pre-specified analyses and transparency.

Full text (72,978 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.

Telemedicine-supported lifestyle intervention for glycemic control in patients with CHD and T2DM: multicenter, randomized controlled trial.

DOI

10.1038/s41591-025-03498-w

Record issued

2026-08-15

Engine

7.39.0

Exported

2026-09-22