Kaimen Rigor reviewed

Rigor-Reviewed Manuscript

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.

Name: Kaimen Rigor review — 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.
Item: 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.
Rating: 94
Author: Alpha1

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

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Kaimen Rigor review — 4.25★ (Strong), 0 critical, 2 high issues for “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.”

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This rigor review was examined and confirmed by Alpha1 Editorial · August 16, 2026

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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.

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DOI

10.1016/S0140-6736(24)00064-3

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Kaimen Rigor reviewed

Rigor-Reviewed Manuscript

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.

Paper source

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 16, 2026

Kaimen Rigor review

Kaimen Rigor reviewed

4.25 / 5

Strong — minor issues to address

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

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

01Treatment effect not shown to be clinically meaningful
highOverreachreviewer-assessedFull detail
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.”
Find in source

Findings by category

01ArithmeticNone found 202OverreachOverstated conclusions 03AuthenticityNone found 104DisclosureReporting gaps 05AvailabilityNone found 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 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 found

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.

Checked — nothing surfaced.

Recomputed 7 tests: 7 consistent, 0 inconsistent; 3 recomputed directly from the reported test statistics, 4 via agent-written checks.

Overstated conclusions

2 findings · worst high

Conclusions that reach past what the paper's own results support — including a significance claim that no longer holds when the statistic is recomputed, and efficacy resting on an unvalidated surrogate endpoint.

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.

Premise concern: effect size not shown to be clinically meaningful.

Data authenticity concerns

None found

An adversarial read for patterns associated with data that may not be genuine: results that look too clean, implausibly large effects, duplicated data or images, and methods that do not match the results reported.

Checked — nothing surfaced.

Reporting gaps

1 finding · worst medium

Required detail the manuscript never states — study design, biological variables, ethics approval and consent, key resources, statistical reporting, data and code availability, and overall transparency.

Data/code availability incompleteAssessed

Eight Dimensions7 pass · 1 warn

The introduction cites prior research on 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.

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

The paper clearly establishes the scientific premise by citing prior work on KMC, including the iKMC and eKMC trials, and provides a logical rationale linking the evidence gap to the study objectives.

Evidence

paraphrase[Introduction, paragraph 3]

“One trial coordinated by WHO (the iKMC trial)... reported that immediate KMC led to a 25% reduction in their secondary outcome of mortality within 28 days... Another trial conducted in a level 2 neonatal unit in The Gambia found no reduction in mortality with KMC before stabilisation compared with standard care; however, this study was underpowered because of improvements in the quality of standard care...”

“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.”

Introduction ¶4Find in source

paraphrase[Introduction, paragraph 4]

“Indeed, there are few economic evaluations of KMC overall... no report has considered household opportunity costs or focused on KMC among neonates before stabilisation.”

PASSReviewer 2· 95% conf

The paper establishes a clear scientific premise, citing prior trials and identifying an evidence gap, with a logical rationale linking the premise to the study objectives.

Evidence

paraphrase[Introduction, paragraph 3]

Introduction ¶3Find in source

“We aimed to compare the effectiveness and safety of KMC initiated before stabilisation versus standard care among neonates ≤2000 g in sub-Saharan Africa.”

Introduction ¶4Find in source

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.

Sub-criteria

controlsN/A

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 study design is rigorous: it is an individually randomised controlled trial with computer-generated allocation, stratification, allocation concealment, and masked analysis. Sample size calculation, inclusion/exclusion criteria, and handling of missing data are well described.

Evidence

“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.”

MethodsFind in source

“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.”

Statistical analysisFind in source

“the independent statistician who conducted the analyses was masked to treatment allocation.”

MethodsFind in source

PASSReviewer 2· 95% conf

The trial design is rigorous: computer-generated randomisation with allocation concealment, masked analysis, a priori sample size calculation, and pre-specified inclusion/exclusion criteria.

Evidence

“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.”

MethodsFind in source

“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.”

MethodsFind in source

Statistical analysisFind in source

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.

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· 95% conf

Biological variables are well reported: sex, age, weight, gestational age, and birthweight are provided for both groups. Demographics (maternal age, education, income) are also reported. Species/strain and housing conditions are not applicable for a human trial.

Evidence

paraphrase[Table 1]

“Sex: Female 558 (50.3%) [intervention], 561 (50.5%) [control]; Male 552 (49.7%) [intervention], 550 (49.5%) [control]”

paraphrase[Table 1]

“Age at screening, h: 20.3 (11.6) [intervention], 21.5 (11.5) [control]; Gestational age at screening, weeks: 32.3 (2.4) [intervention], 32.3 (2.2) [control]; Weight at screening, kg: 1.5 (0.3) [intervention], 1.5 (0.3) [control]”

paraphrase[Table 1]

“Mothers: Age (actual or estimated), years: 25.6 (6.0) [intervention], 25.6 (6.2) [control]; Highest level of education: Primary school 332 (35.3%) [intervention], 349 (37.0%) [control]”

PASSReviewer 2· 95% conf

Biological variables are well reported: sex, age, weight, and health status are provided for neonates; maternal demographics are also reported.

Evidence

“Female | 558 (50·3%) | 561 (50·5%)”

Table 1Find in source

“Age at screening, h | 20·3 (11·6) | 21·5 (11·5)”

Table 1Find in source

“Age (actual or estimated), years | 25·6 (6·0) | 25·6 (6·2)”

Table 1Find in source

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.

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

Ethical approvals are clearly reported: the study was approved by named ethics committees (UVRI, UNCST, LSHTM) with protocol numbers, and written informed consent was obtained. Regulatory compliance is stated.

Evidence

“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).”

MethodsFind in source

“Written informed parental consent was obtained for all participants.”

MethodsFind in source

paraphrase[Methods, Study design]

“This trial is reported in accordance with CONSORT guidelines... The trial was overseen by a steering committee and an independent data and safety monitoring board.”

PASSReviewer 2· 95% conf

Ethical approvals are clearly documented with named ethics committees and informed consent; regulatory compliance is stated.

Evidence

MethodsFind in source

“Written informed parental consent was obtained for all participants.”

MethodsFind in source

paraphrase[Methods, Study design]

“This trial is reported in accordance with CONSORT guidelines (p 4).”

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.

Sub-criteria

mycoplasma testingN/A

reagents identifiedN/A

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Key resources are adequately identified: the investigational product (KMC) is described, and software tools (Stata, REDCap, Microsoft Excel) are named with versions. No antibodies, cell lines, or organisms are used, so those criteria are not applicable.

Evidence

“All statistical analyses were performed with Stata (version 18.1).”

Statistical analysisFind in source

“Data were captured electronically in REDCap by use of trial-specific care report forms”

MethodsFind in source

“All analyses were performed with Microsoft Excel and Stata (version 18.1).”

MethodsFind in source

PASSReviewer 2· 90% conf

The investigational product (KMC) is described in detail, and software tools are identified; no bench reagents are applicable.

Evidence

“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.”

MethodsFind in source

“All statistical analyses were performed with Stata (version 18.1).”

Statistical analysisFind in source

paraphrase[Methods, Procedures]

“Data were captured electronically in REDCap by use of trial-specific care report forms...”

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.

Sub-criteria

tests namedADEQUATE

exact p valuesADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedADEQUATE

assumptions verifiedINADEQUATE

mathematical plausibilityPASS

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Statistical analysis is rigorous: tests are named (modified Poisson, Cox proportional hazards, linear regression), exact p-values are reported, effect sizes with 95% CIs are provided, and software is identified. Assumptions are not explicitly verified but the methods used are standard for clinical trials. Data presentation includes per-group Ns and CIs.

Evidence

“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).”

Results ¶2Find in source

“All statistical analyses were performed with Stata (version 18.1).”

Statistical analysisFind in source

paraphrase[Table 2]

“Mortality at 7 days: 81/1083 (7.5%) [intervention], 83/1102 (7.5%) [control]; adjusted RR 0.97 (0.74 to 1.28); p=0.85”

PASSReviewer 2· 90% conf

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

Evidence

“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.”

Statistical analysisFind in source

“adjusted RR 0·97 [95% CI 0·74–1·28]; p=0·85”

Results ¶3Find in source

“adjusted RR 0·97 [95% CI 0·74–1·28]”

Results ¶3Find in source

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.

Sub-criteria

code sharingNOT REPORTED

accession numbersN/A

repository depositINADEQUATE

data availability statementINADEQUATE

Per reviewer (2) — the votes behind the verdict

WARNReviewer 1· 85% conf

A data availability statement is present, but it is vague: data will be deposited at LSHTM Data Compass with access subject to approval, but no timeline or conditions are specified. Code sharing is not mentioned.

Evidence

paraphrase[Data sharing section]

“Data from the study will be deposited online at LSHTM Data Compass (https://datacompass.lshtm.ac.uk/), with access subject to approval.”

absence[Data sharing section]

Code sharing is not mentioned.

PASSReviewer 2· 90% conf

Data availability is stated with a concrete access route (LSHTM Data Compass), and the trial is registered; code sharing is not applicable.

Evidence

“Data from the study will be deposited online at LSHTM Data Compass ( https://datacompass.lshtm.ac.uk/ ), with access subject to approval.”

Data availabilityFind in source

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.

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineADEQUATE

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

Reporting is transparent: methods are detailed, the trial is registered (NCT02811432), CONSORT and CHEERS guidelines are referenced, all outcomes are reported, limitations are discussed, and conclusions are proportional. Funding and COI are stated.

Evidence

paraphrase[Abstract, Methods]

“This trial is registered with ClinicalTrials.gov (http://Clinicaltrials.gov), NCT02811432 (https://clinicaltrials.gov/ct2/show/NCT02811432).”

paraphrase[Methods, Study design; Methods, Economic evaluation]

“This trial is reported in accordance with CONSORT guidelines... The economic evaluation is reported in accordance with CHEERS guidelines”

paraphrase[Discussion, paragraph 5]

“This trial also had limitations. Our sample size assumed a baseline mortality rate of 25%... we observed lower reductions in mortality rate than were expected... Given the nature of KMC, it was impossible to mask participants and hospital staff to treatment allocation...”

PASSReviewer 2· 95% conf

The manuscript is transparent: methods are detailed, trial is registered, reporting guidelines are followed, limitations are discussed, and funding/COI are declared.

Evidence

“This trial is registered with ClinicalTrials.gov (http://Clinicaltrials.gov) , NCT02811432 (https://clinicaltrials.gov/ct2/show/NCT02811432) .”

MethodsFind in source

paraphrase[Methods, Study design]

“This trial is reported in accordance with CONSORT guidelines (p 4).”

“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).”

Discussion ¶6Find in source

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

Broken references and links

None found

References checked against Crossref, OpenAlex and Retraction Watch for retractions and resolvability, plus declared data and code links probed for whether they resolve to content matching the paper.

Checked — nothing surfaced.

Checked 44 references by DOI: 37 verified — 7 no DOI (shown, not verified).

1 data/code link checked; 1 live.

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 consistency, clarity, other.

Kaimen Rigor Action ItemsFinal pass before journal submission

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 code
In 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 code
Add 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.
MEDIUMstatistics
In 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.
MEDIUMreporting
In 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.
MEDIUMreporting
In 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.
MEDIUMreporting
In 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.
LOWcopyedit
Fix 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.
LOWcopyedit
Fix the extra semicolon and space in Results, paragraph 3: change 'p=0·23; ).' to 'p=0·23).'.
Copyedit flagged a formatting error.
9.
LOWcopyedit
Ensure 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.

Full text (63,038 chars)Analyzed: Aug 16, 2026

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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.

Read full text (PMC)

DOI

10.1016/S0140-6736(24)00064-3

Share this Kaimen Rigor review

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Record fingerprint

f11eb619ddfc862cdd7ac4abe33dacf4631b79a8a951fb2647cbccdf9579b6f6

Verify via API

Issued Aug 16, 2026Engine 7.39.0

Alpha1 assesses methodological rigor, not the importance of the findings. See how we calibrate →

Kaimen Rigor review

Kaimen Rigor reviewed

4.25 / 5

Strong — minor issues to address

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

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

01Treatment effect not shown to be clinically meaningful
highOverreachreviewer-assessedFull detail
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.”
Find in source

Findings by category

01ArithmeticNone found 202OverreachOverstated conclusions 03AuthenticityNone found 104DisclosureReporting gaps 05AvailabilityNone found 06Copyedit7 minor suggestions

Numerical inconsistencies

None found

Checked — nothing surfaced.

Recomputed 7 tests: 7 consistent, 0 inconsistent; 3 recomputed directly from the reported test statistics, 4 via agent-written checks.

Overstated conclusions

2 findings · worst high

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.

Premise concern: effect size not shown to be clinically meaningful.

Data authenticity concerns

None found

Checked — nothing surfaced.

Reporting gaps

1 finding · worst medium

Data/code availability incompleteAssessed

Eight Dimensions7 pass · 1 warn

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

Evidence

paraphrase[Introduction, paragraph 3]

Introduction ¶4Find in source

paraphrase[Introduction, paragraph 4]

“Indeed, there are few economic evaluations of KMC overall... no report has considered household opportunity costs or focused on KMC among neonates before stabilisation.”

PASSReviewer 2· 95% conf

The paper establishes a clear scientific premise, citing prior trials and identifying an evidence gap, with a logical rationale linking the premise to the study objectives.

Evidence

paraphrase[Introduction, paragraph 3]

Introduction ¶3Find in source

“We aimed to compare the effectiveness and safety of KMC initiated before stabilisation versus standard care among neonates ≤2000 g in sub-Saharan Africa.”

Introduction ¶4Find in source

Sub-criteria

controlsN/A

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

Evidence

MethodsFind in source

Statistical analysisFind in source

“the independent statistician who conducted the analyses was masked to treatment allocation.”

MethodsFind in source

PASSReviewer 2· 95% conf

The trial design is rigorous: computer-generated randomisation with allocation concealment, masked analysis, a priori sample size calculation, and pre-specified inclusion/exclusion criteria.

Evidence

“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.”

MethodsFind in source

Statistical analysisFind 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· 95% conf

Evidence

paraphrase[Table 1]

“Sex: Female 558 (50.3%) [intervention], 561 (50.5%) [control]; Male 552 (49.7%) [intervention], 550 (49.5%) [control]”

paraphrase[Table 1]

“Mothers: Age (actual or estimated), years: 25.6 (6.0) [intervention], 25.6 (6.2) [control]; Highest level of education: Primary school 332 (35.3%) [intervention], 349 (37.0%) [control]”

PASSReviewer 2· 95% conf

Biological variables are well reported: sex, age, weight, and health status are provided for neonates; maternal demographics are also reported.

Evidence

“Female | 558 (50·3%) | 561 (50·5%)”

Table 1Find in source

“Age at screening, h | 20·3 (11·6) | 21·5 (11·5)”

Table 1Find in source

“Age (actual or estimated), years | 25·6 (6·0) | 25·6 (6·2)”

Table 1Find in source

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

Evidence

MethodsFind in source

“Written informed parental consent was obtained for all participants.”

MethodsFind in source

paraphrase[Methods, Study design]

“This trial is reported in accordance with CONSORT guidelines... The trial was overseen by a steering committee and an independent data and safety monitoring board.”

PASSReviewer 2· 95% conf

Ethical approvals are clearly documented with named ethics committees and informed consent; regulatory compliance is stated.

Evidence

MethodsFind in source

“Written informed parental consent was obtained for all participants.”

MethodsFind in source

paraphrase[Methods, Study design]

“This trial is reported in accordance with CONSORT guidelines (p 4).”

Sub-criteria

mycoplasma testingN/A

reagents identifiedN/A

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Evidence

“All statistical analyses were performed with Stata (version 18.1).”

Statistical analysisFind in source

“Data were captured electronically in REDCap by use of trial-specific care report forms”

MethodsFind in source

“All analyses were performed with Microsoft Excel and Stata (version 18.1).”

MethodsFind in source

PASSReviewer 2· 90% conf

The investigational product (KMC) is described in detail, and software tools are identified; no bench reagents are applicable.

Evidence

“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.”

MethodsFind in source

“All statistical analyses were performed with Stata (version 18.1).”

Statistical analysisFind in source

paraphrase[Methods, Procedures]

“Data were captured electronically in REDCap by use of trial-specific care report forms...”

Sub-criteria

tests namedADEQUATE

exact p valuesADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedADEQUATE

assumptions verifiedINADEQUATE

mathematical plausibilityPASS

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Evidence

“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).”

Results ¶2Find in source

“All statistical analyses were performed with Stata (version 18.1).”

Statistical analysisFind in source

paraphrase[Table 2]

“Mortality at 7 days: 81/1083 (7.5%) [intervention], 83/1102 (7.5%) [control]; adjusted RR 0.97 (0.74 to 1.28); p=0.85”

PASSReviewer 2· 90% conf

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

Evidence

“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.”

Statistical analysisFind in source

“adjusted RR 0·97 [95% CI 0·74–1·28]; p=0·85”

Results ¶3Find in source

“adjusted RR 0·97 [95% CI 0·74–1·28]”

Results ¶3Find in source

Sub-criteria

code sharingNOT REPORTED

accession numbersN/A

repository depositINADEQUATE

data availability statementINADEQUATE

Per reviewer (2) — the votes behind the verdict

WARNReviewer 1· 85% conf

Evidence

paraphrase[Data sharing section]

“Data from the study will be deposited online at LSHTM Data Compass (https://datacompass.lshtm.ac.uk/), with access subject to approval.”

absence[Data sharing section]

Code sharing is not mentioned.

PASSReviewer 2· 90% conf

Data availability is stated with a concrete access route (LSHTM Data Compass), and the trial is registered; code sharing is not applicable.

Evidence

“Data from the study will be deposited online at LSHTM Data Compass ( https://datacompass.lshtm.ac.uk/ ), with access subject to approval.”

Data availabilityFind in source

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineADEQUATE

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

Evidence

paraphrase[Abstract, Methods]

“This trial is registered with ClinicalTrials.gov (http://Clinicaltrials.gov), NCT02811432 (https://clinicaltrials.gov/ct2/show/NCT02811432).”

paraphrase[Methods, Study design; Methods, Economic evaluation]

“This trial is reported in accordance with CONSORT guidelines... The economic evaluation is reported in accordance with CHEERS guidelines”

paraphrase[Discussion, paragraph 5]

PASSReviewer 2· 95% conf

The manuscript is transparent: methods are detailed, trial is registered, reporting guidelines are followed, limitations are discussed, and funding/COI are declared.

Evidence

“This trial is registered with ClinicalTrials.gov (http://Clinicaltrials.gov) , NCT02811432 (https://clinicaltrials.gov/ct2/show/NCT02811432) .”

MethodsFind in source

paraphrase[Methods, Study design]

“This trial is reported in accordance with CONSORT guidelines (p 4).”

Discussion ¶6Find in source

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

Broken references and links

None found

References checked against Crossref, OpenAlex and Retraction Watch for retractions and resolvability, plus declared data and code links probed for whether they resolve to content matching the paper.

Checked — nothing surfaced.

Checked 44 references by DOI: 37 verified — 7 no DOI (shown, not verified).

1 data/code link checked; 1 live.

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 consistency, clarity, other.

Kaimen Rigor Action ItemsFinal pass before journal submission

1.
HIGHdata code
In 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 code
Add 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.
MEDIUMstatistics
In 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.
MEDIUMreporting
In 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.
MEDIUMreporting
In 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.
MEDIUMreporting
In 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.
LOWcopyedit
Fix 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.
LOWcopyedit
Fix the extra semicolon and space in Results, paragraph 3: change 'p=0·23; ).' to 'p=0·23).'.
Copyedit flagged a formatting error.
9.
LOWcopyedit
Ensure 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.

Full text (63,038 chars)Analyzed: Aug 16, 2026