Effectiveness of kangaroo mother care before clinical stabilisation versus standard care among neonates at five hospitals in Uganda (OMWaNA): a parallel-group, individually randomised controlled trial and economic evaluation.
Tumukunde V, Medvedev MM, Tann CJ, Mambule I, Pitt C, Opondo C, Kakande A, Canter R, Haroon Y, Kirabo-Nagemi C, Abaasa A, Okot W, Katongole F, Ssenyonga R, Niombi N, Nanyunja C, Elbourne D, Greco G, Ekirapa-Kiracho E, Nyirenda M, Allen E, Waiswa P, Lawn JE, OMWaNA Collaborative Authorship Group
- DOI
- 10.1016/S0140-6736(24)00064-3
- Record issued
- 2026-08-16
- 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/1559cd52-5d9c-402f-9c7f-12296b550a0a is authoritative.
How this rating was calculated
- ClaimsTreatment effect not shown to be clinically meaningful−0.5★
- ReportingData & code availability partially met−0.25★
- 01Treatment effect not shown to be clinically meaningful
The primary outcome showed no significant effect (RR 0.97, 95% CI 0.74-1.28). The secondary outcome of 28-day mortality showed a non-significant 12% relative reduction (RR 0.88, 95% CI 0.71-1.09). The pooled meta-analysis showed a 19% relative reduction in 28-day mortality, but this is not the primary trial result. The effect size is not anchored to a minimal clinically important difference, and the primary outcome is null.
“KMC initiated before stabilisation did not reduce early neonatal mortality; however, it was cost-effective from the societal and provider perspectives compared with standard care.”
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 and transparently reported randomised controlled trial of kangaroo mother care before stabilisation versus standard care in Ugandan neonates. The main methodological strengths are rigorous randomisation, clear reporting of biological variables, ethical approvals, and statistical methods. The primary weakness is the vague data availability statement and lack of code sharing, which limits reproducibility.
Both reviewers classified the study as interventional (RCT), so no divergence on study type. The evaluation covered all eight dimensions; several sub-criteria were marked not applicable for a human trial (e.g., species/strain, housing, IACUC). The statistics verification recomputed 7 reported tests, all consistent, but this does not certify the entire analysis. The citation check found no retracted or unresolved references.
Numerical inconsistencies
None foundValues 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.
Checked — nothing surfaced.
Recomputed 7 tests: 7 consistent, 0 inconsistent; 3 recomputed directly from the reported test statistics, 4 via agent-written checks.
- CONSISTENTreported p = .850 · recomputed p = .828Recomputed RR 0.97 (95% CI 0.74–1.28), reported p=0.85
“RR 0.97 [95% CI 0.74–1.28]; p=0.85”
Taken as given: 0.74–1.28 is a two-sided 95% confidence interval for the RR of 0.97, not a range, an IQR, or a different interval level; the RR is a RATIO measure, so the interval is symmetric on the log scale; p=0.85 is the p for THIS estimate, not for another comparison in the same sentenceMethod: back the two-tailed p out of the log-scale CI width and compare it against the printed pHow we recomputed it: pCI(0.97, 0.74, 1.28, 1) - CONSISTENTreported p = .072 · recomputed p = .068Recomputed RR 0.60 (95% CI 0.35–1.05), reported p=0.072
“RR 0.60 [95% CI 0.35–1.05]; p=0.072”
Taken as given: 0.35–1.05 is a two-sided 95% confidence interval for the RR of 0.60, not a range, an IQR, or a different interval level; the RR is a RATIO measure, so the interval is symmetric on the log scale; p=0.072 is the p for THIS estimate, not for another comparison in the same sentenceMethod: back the two-tailed p out of the log-scale CI width and compare it against the printed pHow we recomputed it: pCI(0.6, 0.35, 1.05, 1) - CONSISTENTreported p = .043 · recomputed p = .050Recomputed RR 0.86 (95% CI 0.74–1.00), reported p=0.043
“RR 0.86 [95% CI 0.74–1.00]; p=0.043”
Taken as given: 0.74–1.00 is a two-sided 95% confidence interval for the RR of 0.86, not a range, an IQR, or a different interval level; the RR is a RATIO measure, so the interval is symmetric on the log scale; p=0.043 is the p for THIS estimate, not for another comparison in the same sentenceMethod: back the two-tailed p out of the log-scale CI width and compare it against the printed pHow we recomputed it: pCI(0.86, 0.74, 1, 1) - CONSISTENTreported p = .850 · recomputed p = .828Reviewers 1, 2Primary outcome: 7-day mortality, adjusted RR
“adjusted RR 0·97 [95% CI 0·74–1·28]; p=0·85”
Taken as given: The RR is 0.97; The 95% CI is 0.74 to 1.28; The CI is two-sided at 95%; The test is two-tailedMethod: p-value derived from the reported RR and its 95% CI using the pCI function for a ratio (log=1).How we recomputed it: pCI(0.97, 0.74, 1.28, 1) - CONSISTENTreported p = .230 · recomputed p = .242Reviewers 1, 2Secondary outcome: 28-day mortality, adjusted RR
“adjusted RR 0·88 [95% CI 0·71–1·09]; p=0·23”
Taken as given: The RR is 0.88; The 95% CI is 0.71 to 1.09; The CI is two-sided at 95%; The test is two-tailedMethod: p-value derived from the reported RR and its 95% CI using the pCI function for a ratio (log=1).How we recomputed it: pCI(0.88, 0.71, 1.09, 1) - CONSISTENTreported p < .001 · recomputed p = <.001Reviewer 1Hypothermia at 24h, adjusted RR
“adjusted RR 0·76 [95% CI 0·70–0·83]; p<0·0001”
Taken as given: The RR is 0.76; The 95% CI is 0.70 to 0.83; The CI is two-sided at 95%; The test is two-tailedMethod: p-value derived from the reported RR and its 95% CI using the pCI function for a ratio (log=1). The reported p<0.0001 is consistent with a very small p-value.How we recomputed it: pCI(0.76, 0.70, 0.83, 1) - CONSISTENTreported p < .001 · recomputed p = <.001Reviewer 2Hypothermia at 24h adjusted RR p-value
“adjusted RR 0·76 [95% CI 0·70–0·83]; p<0·0001”
Taken as given: The RR is 0.76 with 95% CI 0.70 to 0.83.; The p-value is two-sided from the same model that produced the CI.Method: Recomputed two-sided p-value from the reported RR and 95% CI using the normal approximation for the log-RR.How we recomputed it: pCI(0.76, 0.70, 0.83, 1)
Overstated conclusions
2 findings · worst highConclusions 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.
- Treatment effect not shown to be clinically meaningfulAssessed
- Conclusions only partially backed by the presented evidenceAssessed
10 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.
- partialReviewer 1KMC before stabilisation decreased the economic cost of neonatal care to society and providers.The overall mean cost difference was not statistically significant (adjusted mean difference -$7.2, 95% CI -21.5 to 7.2, p=0.33), but the paper argues cost-effectiveness through net benefit analysis. The claim of 'decreased cost' is not fully supported by the primary cost analysis.Evidence: Results, economic evaluation: 'the mean economic cost to society per neonate (n=2221) was similar between the intervention group (US$359·1) and the control group ($365·9; adjusted mean difference –$7·2 [95% CI –21·5 to 7·2]; p=0·33).'
the mean economic cost to society per neonate (n=2221) was similar between the intervention group (US$359·1) and the control group ($365·9; adjusted mean difference –$7·2 [95% CI –21·5 to 7·2]; p=0·33).
Resultsreviewer’s wording - supportedReviewer 1KMC initiated before stabilisation did not reduce early neonatal mortality (7-day mortality).The paper's primary outcome shows no significant difference (adjusted RR 0.97, 95% CI 0.74-1.28, p=0.85), supporting this claim.Evidence: Table 2: 81/1083 (7.5%) intervention vs 83/1102 (7.5%) control; adjusted RR 0.97 (0.74-1.28), p=0.85.
“KMC initiated before stabilisation did not reduce early neonatal mortality”
AbstractFind in source - supportedReviewer 1KMC initiated before stabilisation was cost-effective from the societal and provider perspectives.The economic evaluation shows a high probability of cost-effectiveness (97% provider, 84% societal) even when no value is placed on averting deaths, supporting the claim.Evidence: Results, economic evaluation: 'the intervention would have 97% probability from the provider perspective and 84% probability from the societal perspective of being more cost-effective than standard care.'
“the intervention would have 97% probability from the provider perspective and 84% probability from the societal perspective of being more cost-effective than standard care.”
AbstractFind in source - supportedReviewer 1KMC before stabilisation reduced hypothermia at 24 hours.The secondary outcome shows a significant reduction in hypothermia (adjusted RR 0.76, 95% CI 0.70-0.83, p<0.0001), supporting the claim.Evidence: Table 2: 448/1096 (40.9%) intervention vs 585/1101 (53.1%) control; adjusted RR 0.76 (0.70-0.83), p<0.0001.
“The proportion of neonates with hypothermia at 24 h was 40·9% (448 of 1096) in the intervention group and 53·1% (585 of 1101) in the control group (adjusted RR 0·76 [95% CI 0·70–0·83]; p<0·0001).”
Results ¶3Find in source - supportedReviewer 1A pooled meta-analysis of three trials shows a 19% relative reduction in 28-day mortality.The paper reports a meta-analysis of OMWaNA, iKMC, and eKMC trials showing a significant reduction (RR 0.81, 95% CI 0.71-0.93, p=0.0019), supporting the claim.Evidence: Results, paragraph 4: 'A pooled meta-analysis... showed a relative reduction of 19% in 28-day mortality (95% CI 0·71–0·93; p=0·0019).'
A pooled meta-analysis of the OMWaNA trial, WHO’s iKMC trial, and the eKMC trial in The Gambia showed a relative reduction of 19% in 28-day mortality (95% CI 0·71–0·93; p=0·0019).
Results ¶4reviewer’s wording - supportedReviewer 2KMC initiated before stabilisation did not reduce early neonatal mortality.The primary outcome analysis shows no significant difference in 7-day mortality, supporting the claim.Evidence: Primary outcome: adjusted RR 0·97 [95% CI 0·74–1·28]; p=0·85.
“KMC initiated before stabilisation did not reduce early neonatal mortality; however, it was cost-effective from the societal and provider perspectives compared with standard care.”
AbstractFind in source - supportedReviewer 2KMC initiated before stabilisation was cost-effective from societal and provider perspectives.The economic evaluation shows high probability of cost-effectiveness, supporting the claim.Evidence: Incremental net benefit analysis shows 97% probability from provider perspective and 84% from societal perspective of being more cost-effective.
“KMC initiated before stabilisation did not reduce early neonatal mortality; however, it was cost-effective from the societal and provider perspectives compared with standard care.”
AbstractFind in source - supportedReviewer 2A pooled meta-analysis of three trials showed a significant relative reduction in 28-day mortality of 19%.The pooled analysis is reported with a significant p-value, supporting the claim.Evidence: Pooled meta-analysis: relative reduction of 19% in 28-day mortality (95% CI 0·71–0·93; p=0·0019).
“A pooled meta-analysis of the OMWaNA trial, WHO’s iKMC trial, and the eKMC trial in The Gambia showed a relative reduction of 19% in 28-day mortality (95% CI 0·71–0·93; p=0·0019; ).”
Results ¶8Find in source - supportedReviewer 2KMC initiated before stabilisation decreased the economic cost of neonatal care to society and providers.The economic evaluation shows lower mean costs in the intervention group, supporting the claim.Evidence: Mean economic cost to society per neonate was similar, but provider costs were lower in the intervention group (adjusted mean difference –$9·4 [–19·0 to 0·3]; p=0·058).
“Our economic evaluation found that, compared with standard care, KMC initiated before stabilisation decreased the economic cost of neonatal care to society and providers.”
Discussion ¶1Find in source - supportedReviewer 2KMC initiated before stabilisation improved secondary outcomes including hypothermia and daily weight gain.Secondary outcomes show significant improvements in hypothermia and weight gain, supporting the claim.Evidence: Hypothermia at 24h: adjusted RR 0·76 [95% CI 0·70–0·83]; p<0·0001. Daily weight gain: adjusted mean difference 0·75 [0·01–1·49]; p=0·047.
“Secondary outcomes, including hypothermia at 24 h and daily weight gain at 28 days, were significantly improved among neonates in the intervention group.”
Discussion ¶1Find in source
Premise concern: effect size not shown to be clinically meaningful.
- ADEQUATESurrogate endpointThe primary outcome is all-cause neonatal mortality at 7 days, a hard clinical outcome. Secondary outcomes include mortality at 28 days, hypothermia, time to stabilisation, and weight gain. The efficacy claim is based on mortality, not a surrogate.
“The primary outcome was all-cause neonatal mortality at 7 days, analysed by intention to treat.”
- INADEQUATEEffect sizeThe primary outcome showed no significant effect (RR 0.97, 95% CI 0.74-1.28). The secondary outcome of 28-day mortality showed a non-significant 12% relative reduction (RR 0.88, 95% CI 0.71-1.09). The pooled meta-analysis showed a 19% relative reduction in 28-day mortality, but this is not the primary trial result. The effect size is not anchored to a minimal clinically important difference, and the primary outcome is null.
“KMC initiated before stabilisation did not reduce early neonatal mortality; however, it was cost-effective from the societal and provider perspectives compared with standard care.”
Data authenticity concerns
None foundAn 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 mediumRequired 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
The introduction cites prior research on KMC, including the WHO iKMC trial and the eKMC trial in The Gambia, and acknowledges their strengths and limitations (e.g., underpowering, context differences). The rationale for the study is clearly stated: to address the evidence gap on KMC before stabilisation in sub-Saharan African facilities without neonatal intensive care. Limitations of prior work (e.g., lack of economic evaluations, focus on level 3 hospitals) are explicitly addressed as gaps the current study aims to fill.
“The findings of these two trials left an evidence gap regarding the effects of immediate KMC at facilities without neonatal intensive care, where most births in LMICs occur, and questions regarding possibly lower impact in sub-Saharan Africa.”
“The findings of these two trials left an evidence gap regarding the effects of immediate KMC at facilities without neonatal intensive care, where most births in LMICs occur, and questions regarding possibly lower impact in sub-Saharan Africa.”
“We aimed to compare the effectiveness and safety of KMC initiated before stabilisation versus standard care among neonates ≤2000 g in sub-Saharan Africa.”
Randomisation was computer-generated with permuted blocks of varying sizes, stratified by birthweight and site, and allocation was concealed via REDCap. The independent statistician was masked to treatment allocation. A sample size calculation was performed (2188 neonates, 80% power, 5% significance). Inclusion and exclusion criteria are clearly defined. The analysis used intention-to-treat with modified Poisson regression. The trial was registered (NCT02811432). For a human RCT, replicate_distinction, controls, and independent_replication are not applicable per the scoring guide. Outlier handling is not explicitly described, but the analysis approach (ITT, modified Poisson) and missing data handling (assuming missing at random) are stated, which is adequate for a clinical trial.
“A random allocation sequence was computer-generated with permuted blocks of varying sizes, stratified by birthweight (700–1000 g, 1000–1499 g, or 1500–2000 g) and recruitment site. Allocation concealment was done by programming the allocation sequence into the screening database and revealing treatment group only when screening of eligible neonates was complete.”
“A sample size of 2188 neonates (1094 per group) was estimated to be required to detect an absolute reduction in 7-day mortality of 5·6% (22·4% relative reduction) at a 5% significance level (two-sided) and 80% power, allowing for 20% attrition.”
“the independent statistician who conducted the analyses was masked to treatment allocation.”
“A random allocation sequence was computer-generated with permuted blocks of varying sizes, stratified by birthweight (700–1000 g, 1000–1499 g, or 1500–2000 g) and recruitment site.”
“Masking of parents, caregivers, or health-care workers was not possible due to the nature of the KMC intervention; however, the independent statistician who conducted the analyses was masked to treatment allocation.”
“A sample size of 2188 neonates (1094 per group) was estimated to be required to detect an absolute reduction in 7-day mortality of 5·6% (22·4% relative reduction) at a 5% significance level (two-sided) and 80% power, allowing for 20% attrition.”
Sex is reported for neonates (Table 1: 50.3% female intervention, 50.5% female control). Age at screening, gestational age, and weight are reported with means and SDs. Maternal demographics (age, education, income) are also reported. Since this is a human trial, species_strain_source and housing_conditions are not applicable. Sex_justified is not applicable because both sexes were enrolled.
“Female | 558 (50·3%) | 561 (50·5%)”
“Age at screening, h | 20·3 (11·6) | 21·5 (11·5)”
“Age (actual or estimated), years | 25·6 (6·0) | 25·6 (6·2)”
The study was approved by the Research Ethics Committees of Uganda Virus Research Institute (GC/127/19/06/717), Uganda National Council of Science and Technology (HS 2645), and London School of Hygiene & Tropical Medicine (16972). Written informed parental consent was obtained. The trial was overseen by a steering committee and an independent data and safety monitoring board. Regulatory compliance is implied through the ethics approvals and the statement that the trial was conducted in accordance with CONSORT guidelines.
“The study was approved by the Research Ethics Committees of Uganda Virus Research Institute (GC/127/19/06/717), Uganda National Council of Science and Technology (HS 2645), and London School of Hygiene & Tropical Medicine (16972).”
“Written informed parental consent was obtained for all participants.”
“The study was approved by the Research Ethics Committees of Uganda Virus Research Institute (GC/127/19/06/717), Uganda National Council of Science and Technology (HS 2645), and London School of Hygiene & Tropical Medicine (16972).”
“Written informed parental consent was obtained for all participants.”
The intervention (KMC) is described in detail (skin-to-skin contact, KMC wrap, adjustable beds). The control group care (incubator/radiant heater) is also described. Software tools are identified: Stata (version 18.1), REDCap, and Microsoft Excel. No antibodies, cell lines, mycoplasma testing, or organisms (beyond human neonates) are applicable. Reagents are not applicable as no chemical reagents are used.
“All statistical analyses were performed with Stata (version 18.1).”
“Data were captured electronically in REDCap by use of trial-specific care report forms”
“All analyses were performed with Microsoft Excel and Stata (version 18.1).”
“Neonates were naked, except for hat and diaper; placed prone and skin-to-skin on the caregiver’s chest; and secured using a KMC wrap.”
“All statistical analyses were performed with Stata (version 18.1).”
All statistical tests are named (modified Poisson regression for RR, Cox proportional hazards for HR, linear regression for mean differences). Exact p-values are reported (e.g., p=0.85, p=0.23). Effect sizes with 95% CIs are provided for all outcomes. Software is identified (Stata 18.1). Data presentation includes per-group Ns, percentages, and CIs. Assumptions_verified is not explicitly reported, but for a clinical trial using standard methods (modified Poisson, Cox), this is acceptable per the scoring guide. Mathematical plausibility checks: the reported percentages and Ns appear consistent (e.g., 81/1083 = 7.48% ≈ 7.5%; 83/1102 = 7.53% ≈ 7.5%). No arithmetic errors are apparent.
“From randomisation to 7 days of age, 81 (7·5%) of 1083 neonates in the intervention group and 83 (7·5%) of 1102 in the control group died (adjusted RR 0·97 [95% CI 0·74–1·28]; p=0·85).”
“All statistical analyses were performed with Stata (version 18.1).”
“Risk ratios (RRs) with 95% CI were estimated for 7-day and 28-day mortality and were compared between the intervention group and the control group with modified Poisson regression models.”
“adjusted RR 0·97 [95% CI 0·74–1·28]; p=0·85”
“adjusted RR 0·97 [95% CI 0·74–1·28]”
The data sharing statement says data will be deposited online at LSHTM Data Compass with access subject to approval, but no details on the approval process or timeline are provided. This is reported_but_inadequate per the scoring guide (vague 'on request' equivalent). Code sharing is not mentioned; since the analysis used standard software (Stata), custom code may not be applicable, but the paper does not address this. Repository_deposit and accession_numbers are not applicable for patient-level data (privacy), but the statement about LSHTM Data Compass suggests a repository deposit is planned, though not yet available.
“Data from the study will be deposited online at LSHTM Data Compass ( https://datacompass.lshtm.ac.uk/ ), with access subject to approval.”
Methods are described in detail (study design, participants, randomisation, procedures, outcomes, statistical analysis). The trial is registered with ClinicalTrials.gov (NCT02811432). CONSORT and CHEERS guidelines are referenced. All pre-specified outcomes are reported in Table 2, including non-significant results. Limitations are discussed (e.g., lower than expected mortality, inability to blind, missing household cost data). Conclusions are proportional: the paper states the intervention did not reduce early mortality but was cost-effective. Funding sources and a COI statement (no competing interests) are provided.
“This trial is registered with ClinicalTrials.gov (http://Clinicaltrials.gov) , NCT02811432 (https://clinicaltrials.gov/ct2/show/NCT02811432) .”
“This trial also had limitations. Our sample size assumed a baseline mortality rate of 25% and the trial was powered to detect a relative risk reduction in the primary outcome (mortality at 7 days).”
Registered (1 ID: ClinicalTrials.gov). Reporting guideline cited: CONSORT.
Broken references and links
None foundReferences 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 44 references by DOI: 37 verified — 7 no DOI (shown, not verified).
- NO DOILevels & trends in child mortality: report 2023No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
- NO DOIBorn too soon: decade of action on preterm birthNo DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
- NO DOIWHO recommendations for care of the preterm or low-birth-weight infantNo DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
- NO DOIThe cost-savings of implementing kangaroo mother care in NicaraguaNo DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
- NO DOIKangaroo mother care: a practical guideNo DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
- NO DOIOfficial exchange rate (LCU per US$, period average)No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
- NO DOIKangaroo mother care: implementation strategy for scale-up adaptable to different country contextsNo DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
1 data/code link checked; 1 live.
- datahttps://datacompass.lshtm.ac.uk/LIVEHTTP 200Resolves, but the content could not be matched to the paper.
Copyediting
7 minorWording, consistency and formatting errors that need correcting before submission.
No major wording or formatting errors. 7 minor suggestions below.
7 copyedit issues flagged: mostly consistency, clarity, other.
- MINORconsistencyAbstract, Results“p=0.85.”→ Add a space before the period: 'p=0.85.'Minor formatting issue.
- MINORconsistencyResults, paragraph 2“p=0.85.”→ Add a space before the period: 'p=0.85.'Same issue as abstract.
- MINORclarityMethods, Statistical analysis“All randomly assigned neonates with complete data at trial endpoints were included in the analysis to provide an unbiased estimate of the intention-to-treat effect, assuming missingness at random.”→ Clarify that this is a modified ITT analysis, as per standard terminology.The phrase 'unbiased estimate' may be overstated; ITT with missing data can still be biased if missingness is not at random.
- MINORconsistencyTable 2“p=0.85”→ Ensure consistent decimal places (e.g., p=0.85 vs p=0.23).Minor formatting.
- MINORotherDiscussion, paragraph 1“KMC initiated before stabilisation would be considered superior to dominate standard care”→ Rephrase for clarity: 'KMC initiated before stabilisation would be considered superior to, or dominate, standard care'Awkward phrasing.
- MINORtypoAbstract, Findings“p=0·85.”→ p=0·85).Missing closing parenthesis.
- MINORconsistencyResults, paragraph 3“p=0·23; ).”→ p=0·23).Extra semicolon and space before parenthesis.
The published work is methodologically robust and transparent, with no integrity red flags. An informed reader should weigh the under-specified data availability statement and the lack of code sharing as minor reproducibility limitations; the statistical recomputations were consistent, but only a subset of tests were verified. No erratum or correction appears warranted based on this audit.
- 1.HIGHdata codeIn the Data Sharing section, specify the timeline for data deposit at LSHTM Data Compass, the conditions for access (e.g., review by a data access committee), and whether de-identified individual patient data will be included.The current statement is vague and does not meet the standard for a concrete data availability statement, which is a reproducibility concern.
- 2.HIGHdata codeAdd a code sharing statement in the Data Sharing section, either stating that no custom code was used or providing access to analysis scripts.Code sharing is not mentioned, and transparency about analysis code is expected for reproducibility.
- 3.MEDIUMstatisticsIn the Methods, Statistical analysis section, explicitly state that assumptions for statistical tests (e.g., proportional hazards for Cox models) were verified, or note that robust standard errors were used to handle violations.Reviewer 1 flagged that assumptions are not explicitly verified; adding this detail strengthens the statistical reporting.
- 4.MEDIUMreportingIn the Methods, Statistical analysis section, clarify that the analysis is a modified intention-to-treat analysis, as per standard terminology, and temper the phrase 'unbiased estimate' to acknowledge potential bias if missingness is not at random.The copyedit pass noted that the current phrasing may overstate the unbiasedness of the ITT estimate.
- 5.MEDIUMreportingIn the Discussion, paragraph 1, rephrase 'KMC initiated before stabilisation would be considered superior to dominate standard care' to 'KMC initiated before stabilisation would be considered superior to, or dominate, standard care'.The copyedit pass flagged awkward phrasing that could confuse readers.
- 6.MEDIUMreportingIn the Discussion, add a note on the generalisability of the economic evaluation findings to other settings.Reviewer 2 suggested this to enhance the applicability of the economic conclusions.
- 7.LOWcopyeditFix the missing closing parenthesis in the Abstract, Findings: change 'p=0·85.' to 'p=0·85).'.Copyedit flagged a typo that could be confusing.
- 8.LOWcopyeditFix the extra semicolon and space in Results, paragraph 3: change 'p=0·23; ).' to 'p=0·23).'.Copyedit flagged a formatting error.
- 9.LOWcopyeditEnsure consistent decimal places for p-values across the manuscript (e.g., p=0.85 vs p=0.23) and add a space before the period in 'p=0.85.' in the Abstract and Results.Copyedit flagged minor formatting inconsistencies.
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.”
- 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.
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.