Kaimen Rigor reviewed

Rigor-Reviewed Manuscript

Intravenous Rehydration for Severe Acute Malnutrition with Gastroenteritis.

Name: Kaimen Rigor review — Intravenous Rehydration for Severe Acute Malnutrition with Gastroenteritis.
Item: Intravenous Rehydration for Severe Acute Malnutrition with Gastroenteritis.
Rating: 59
Author: Alpha1

Maitland K, Ouattara SM, Sainna H, Chara A, Ogundipe OF, Sunyoto T, Hamaluba M, Olupot-Olupot P, Alaroker F, Connon R, Saidou Maguina A, Okiror W, Amorut D, Mwajombo E, Oguda E, Mogaka C, Langendorf C, Dewez JE, Ciglenecki I, Gibb DM, Coldiron ME, Petrucci R, George EC, GASTROSAM Trial Group

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Kaimen Rigor review — 3.5★ (Adequate), 0 critical, 4 high issues for “Intravenous Rehydration for Severe Acute Malnutrition with Gastroenteritis.”

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Intravenous Rehydration for Severe Acute Malnutrition with Gastroenteritis.

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DOI

10.1056/NEJMoa2505752

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5d157da58ca325c11c18b18f62d97e3fa8dadc406435f1be58e858225cea71f8

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Issued Aug 15, 2026Engine 7.39.0

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Kaimen Rigor reviewed

Rigor-Reviewed Manuscript

Intravenous Rehydration for Severe Acute Malnutrition with Gastroenteritis.

Paper source

Intravenous Rehydration for Severe Acute Malnutrition with Gastroenteritis.

Read full text (PMC)

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Links back to this Kaimen Rigor review.

Alpha1 Editorial

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

Kaimen Rigor review

Kaimen Rigor reviewed

3.5 / 5

Adequate — real issues to address

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

IntegrityIntegrity concern−0.5★
ClaimsOverstated claim−0.5★
StatisticsPrinted percentage does not match its own count (capped) ×2−0.25★
ReportingData & code availability partially met−0.25★

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

Not verified in this report

No data or code availability links were detected to verify.

Biggest issues

01Printed percentage does not match its own count
mediumArithmeticrecomputedFull detail
45% does not match the reported count 58/126
“58/126(45%)”
02Printed percentage does not match its own count
mediumArithmeticrecomputedFull detail
9% does not match the reported count 11/138
“11/138 (9%)”
03Conclusion reaches beyond the evidence
mediumOverreachreviewer-assessedFull detail
Current guidance should be reviewed to consider simplifying rehydration protocols, removing the distinction between SAM and non-malnourished children.
“Given the findings of this study, in the absence of other data, we would suggest that current guidance be reviewed to consider simplifying rehydration protocols, removing the distinction in management between SAM and non-malnourished children, which would be…”
DiscussionFind in source

Findings by category

201ArithmeticNumerical inconsistencies 202OverreachOverstated conclusions 03AuthenticityNone found 104DisclosureReporting gaps 05AvailabilityNone found · partly checked 06Copyedit6 minor suggestions

This Kaimen Rigor review uses Kaimen Rigor reviewers trained on a curated corpus of high-fidelity and retracted papers, with expert supervision and curation. It can still make mistakes; verify each finding against the source before relying on it.

This is a well-conducted randomized controlled trial with rigorous design, clear reporting of biological variables, ethical approvals, and statistical methods. The main weakness is the lack of a clear data availability statement and repository deposit, which limits transparency and reproducibility. Minor copyedit issues and a slightly overstated recommendation in the discussion are also noted.

Both reviewers classified the study as interventional (RCT), and this was adopted. The evaluation covered all eight dimensions; non-applicable sub-criteria (e.g., animal housing, cell lines) were excluded. The statistics verification covered only a subset of reported tests (6 tests, 4 consistent, 2 inconsistent but no decision errors), so the statistical analysis is not fully verified. The citation check found no retracted or non-existent references.

Numerical inconsistencies

2 findings · worst medium

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.

Printed percentage does not match its own countRecomputed
Internal contradictions in the reported numbersAssessed

Recomputed 4 tests: 4 consistent, 0 inconsistent; 4 via agent-written checks. 2 printed percentages that do not match their own count.

Overstated conclusions

2 findings · worst medium

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.

Conclusions overstated beyond the evidenceAssessed
Conclusions only partially backed by the presented evidenceAssessed

6 major claims checked against the paper's own evidence: 1 not fully backed by the presented evidence (unsupported or overstated), 1 only partially supported (evidence backs part of the claim; gaps or caveats remain).

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 WHO guidelines and prior studies, acknowledges the lack of evidence for current recommendations, and builds a rationale for testing liberal intravenous rehydration. It also addresses limitations of prior research, such as the FEAST trial's findings on fluid boluses.

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 by citing prior research and guidelines, and provides a logical rationale for the trial.

Evidence

paraphrase[Introduction, paragraph 1-3]

“Current recommendations for rehydration in children with SAM differ from those without SAM . First, intravenous rehydration is not recommended in SAM on the grounds that malnourished children are at high risk of cardiac compromise and sodium overload .”

“Here we hypothesized that liberal intravenous rehydration (either given rapidly or slowly) compared with standard oral rehydration would reduce mortality in children hospitalized with SAM complicated by gastroenteritis .”

IntroductionFind in source

paraphrase[Introduction, paragraph 2-3]

“Although such guidance documents have been in place for over two decades, no prior or subsequent evidence has been provided to support these recommendations .”

PASSReviewer 2· 90% conf

The paper establishes a clear scientific premise by citing prior research, identifying gaps in evidence, and providing a logical rationale for the trial.

Evidence

paraphrase[Introduction, paragraph 1]

“Although such guidance documents have been in place for over two decades, no prior or subsequent evidence has been provided to support these recommendations.”

paraphrase[Introduction, last paragraph]

paraphrase[Introduction]

“The paper does not explicitly discuss limitations of prior studies, but the trial design (randomized, multicenter) addresses the lack of RCT evidence.”

Randomization used computer-generated permuted blocks with opaque sealed envelopes; unit is individual child. Power analysis is stated (80% power to detect 30% relative reduction). Inclusion/exclusion criteria are clearly defined. Blinding is not applicable as it is an open-label trial, but this is stated. Outlier handling is addressed via complete-case analysis and multiple imputation. Controls are the standard WHO SAM strategy. Independent replication is not applicable for a single pivotal trial.

Sub-criteria

controlsADEQUATE

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 clear randomization, blinding of laboratory assessments, and a pre-specified statistical analysis plan.

Evidence

“The statistician in London generated the sequential randomization list, computer-generated using variably-sized permuted blocks. Randomization at sites used consecutively numbered opaque sealed envelopes containing the randomized allocation, opened in numerical order.”

MethodsFind in source

“Study staff were unblinded throughout; laboratory tests were assayed blinded.”

MethodsFind in source

paraphrase[Methods, Statistical Analysis]

“Enrolling 272 children with severe dehydration was anticipated to provide 80% power to detect a 30% relative reduction in 96-hour mortality from 58% in the control group to 41% in the liberal strategies, assuming no lost-to-follow-up by 96hours (2-sided alpha=0.05) .”

PASSReviewer 2· 95% conf

The trial design is rigorous: randomization method and unit are described, power analysis is provided, inclusion/exclusion criteria are pre-specified, and the analysis population is defined.

Evidence

MethodsFind in source

paraphrase[Methods, Statistical Analysis]

“Eligible children aged 6 months to 12 years hospitalized with SAM (defined as either weight-for-height z-score <-3, mid-upper arm circumference (MUAC) <11.5cm or presentation with edematous malnutrition (kwashiorkor) with at least bilateral pedal edema ) with gastroenteritis (>3 loose stools per day) and signs of severe dehydration were included.”

MethodsFind in source

The baseline table reports sex, age, weight, and many clinical and laboratory variables. Both sexes are included, so sex justification is not applicable. Demographics are reported for the trial population.

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

Biological variables and demographics are well reported, including sex, age, weight, and clinical characteristics.

Evidence

“Sex - male | 62 (45%) | 64 (48%) | 28 (42%) | 36 (54%)”

Table 1Find in source

“Age months | 12 (9, 22) | 14 (9, 23) | 16 (9, 24) | 14 (9, 22)”

Table 1Find in source

“Weight (kg) | 5.3 (4.5, 6.1) | 5.2 (4.6, 6.1) | 5.0 (4.5, 6.1) | 5.3 (4.7, 6.1)”

Table 1Find in source

PASSReviewer 2· 90% conf

Biological variables are well reported: sex, age, weight, and health status are provided in baseline characteristics; demographics are detailed.

Evidence

“Sex - male | 62 (45%) | 64 (48%) | 28 (42%) | 36 (54%)”

Table 1Find in source

“Age months | 12 (9, 22) | 14 (9, 23) | 16 (9, 24) | 14 (9, 22)”

Table 1Find in source

“Severe hyponatremia (sodium <125 mmol/L) | 70/131 (53%) | 67/131 (51%) | 35/66 (53%) | 32/65 (49%)”

Table 1Find in source

The protocol was approved by local ethics committees. Informed consent was obtained, with provisions for verbal assent and delayed written consent when needed. Regulatory compliance is implied through 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· 90% conf

Ethical approvals and consent procedures are adequately reported.

Evidence

“The protocol was approved by the local ethics committees and is available at nejm.org (https://www.nejm.org/) .”

MethodsFind in source

“When prior written consent from parents or legal guardians could not be obtained, ethics committees approved verbal assent with delayed written informed consent as soon as practical . Otherwise, written informed consent was obtained from parents or guardians before randomization.”

MethodsFind in source

PASSReviewer 2· 85% conf

Ethical approvals are adequately reported: the protocol was approved by local ethics committees, and informed consent procedures are described.

Evidence

paraphrase[Methods, Trial Design and Oversight]

“The protocol was approved by the local ethics committees and is available at nejm.org.”

MethodsFind in source

absence[Methods]

Regulatory compliance is not explicitly stated.

The trial uses Ringer's Lactate and oral rehydration solutions (ReSoMal and WHO ORS) as key resources, which are identified by name. Statistical software (Stata v18) is identified. No antibodies, cell lines, or other bench reagents are used.

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· 90% conf

The investigational product (Ringer's Lactate) and oral rehydration solutions are identified, and statistical software is named.

Evidence

“liberal:rapid rehydration (WHO Plan C: 100 ml/kg Ringer’s Lactate over 3-6 hours according to age with boluses (20 ml/kg) for those with shock)”

MethodsFind in source

“all participants were simultaneously factorially randomized (1:1) either to ( Re hydration So lution for Mal nutrition (ReSoMal)) or WHO oral rehydration solution (ORS)”

MethodsFind in source

“Analyses used Stata v18.”

Statistical analysisFind in source

PASSReviewer 2· 90% conf

The investigational product (Ringer's Lactate) and oral rehydration solutions are adequately identified, and statistical software is named.

Evidence

“liberal:rapid rehydration (WHO Plan C: 100 ml/kg Ringer’s Lactate over 3-6 hours according to age with boluses (20 ml/kg) for those with shock) or liberal:slow rehydration (100 ml/kg Ringer’s Lactate over 8h and no boluses)”

MethodsFind in source

“Analyses used Stata v18.”

Statistical analysisFind in source

The primary analysis uses Mantel-Haenszel adjusted risk ratio, Cox regression for secondary outcomes, and linear/logistic regression for continuous and binary outcomes. Exact p-values are reported for the primary endpoint. Effect sizes are reported with confidence intervals. Software is identified. Data presentation includes per-group n and appropriate measures.

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· 90% conf

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

Evidence

“Randomized groups were compared with an intention-to-treat analysis using a Mantel-Haenszel adjusted risk ratio for mortality at 96hours (primary endpoint), adjusted for pre-specified covariate of site (hospital), and Cox regression for mortality by 28 days (secondary endpoint).”

Statistical analysisFind in source

“Adjusted Risk Ratio (aRR) (liberal vs. control) =1.02 (95% CI 0.41,2.52); p=0.69”

ResultsFind in source

“Mortality at 96 hours | 11/138 (8%) | 9/134 (7%) | 5/67 (7%) | 4/67 (6%) | 1.02 (0.41,2.52) ; p=0.69”

Table 3Find in source

PASSReviewer 2· 90% conf

Statistical methods are appropriate and well-described: tests are named, effect sizes with CIs are reported, and software is identified.

Evidence

Statistical analysisFind in source

“Adjusted Risk Ratio (aRR) (liberal vs. control) =1.02 (95% CI 0.41,2.52); p=0.69”

ResultsFind in source

“Mortality at 96 hours | 11/138 (8%) | 9/134 (7%) | 5/67 (7%) | 4/67 (6%) | 1.02 (0.41,2.52) ; p=0.69”

Table 3Find in source

The paper states that the protocol is available at NEJM.org, but does not provide a clear data availability statement for the trial data. No repository deposit or accession numbers are mentioned. Code sharing is not applicable as no custom code is described.

Sub-criteria

code sharingN/A

accession numbersN/A

repository depositNOT REPORTED

data availability statementINADEQUATE

Per reviewer (2) — the votes behind the verdict

WARNReviewer 1· 80% conf

A data availability statement is present but vague, and no data or code repositories are mentioned.

Evidence

“The protocol was approved by the local ethics committees and is available at nejm.org (https://www.nejm.org/) .”

MethodsFind in source

absence[Full text]

No repository deposit is mentioned.

WARNReviewer 2· 80% conf

A data availability statement is present but vague, and no data repository or code is provided.

Evidence

absence[End of paper]

No data availability statement is present.

“The protocol was approved by the local ethics committees and is available at nejm.org (https://www.nejm.org/) .”

MethodsFind in source

The trial is registered (ISRCTN76149273). Methods are detailed enough for replication. Limitations are discussed, including lower-than-expected mortality and generalizability. Conclusions are cautious and proportional. Funding and COI are disclosed.

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 trial is registered, methods are detailed, limitations are discussed, and conclusions are proportional.

Evidence

“GASTROSAM Current Controlled Trials number, ISRCTN76149273”

AbstractFind in source

“The key limitation of our trial was the much lower overall mortality (9%) than we predicted from two small studies, which reported mortality at hospital discharge or 28 days as 68-82% , , at the high end compared with other observational data.”

Discussion ¶1Find in source

“Funded by the Joint Global Health Trials Scheme of the United Kingdom’s Medical Research Council, the UK Department for International Development and Wellcome (Grant Number MR/R018502/1) and by Médecins Sans Frontières”

FundingFind in source

PASSReviewer 2· 90% conf

Reporting is transparent: trial registration is provided, limitations are discussed, conclusions are proportional, and funding/COI are disclosed.

Evidence

“GASTROSAM Current Controlled Trials number, ISRCTN76149273”

AbstractFind in source

“The key limitation of our trial was the much lower overall mortality (9%) than we predicted from two small studies, which reported mortality at hospital discharge or 28 days as 68-82%”

Discussion ¶1Find in source

FundingFind in source

Registered (1 ID: ISRCTN). No reporting guideline cited.

Broken references and links

None found · partly checked

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.

Nothing surfaced — but not everything feeding this category ran (missing: data/code link verification), so read this as a partial clean bill.

Checked 24 references by DOI: 19 verified — 5 no DOI (shown, not verified).

Copyediting

6 minor

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

No major wording or formatting errors. 6 minor suggestions below.

6 copyedit issues flagged: mostly consistency, typo, grammar.

Kaimen Rigor Action ItemsFinal pass before journal submission

The published work is robust and generally well-reported, but an informed reader should weigh the lack of a clear data availability statement and the minor internal inconsistency in the primary outcome CI between the abstract and results. These issues do not invalidate the findings but warrant attention; a correction or clarification would strengthen the record.

1.
HIGHdata code
Add a clear data availability statement in the Methods or a dedicated section, specifying how de-identified participant data can be accessed (e.g., via a data access committee or repository) and any conditions.
The current statement only mentions the protocol availability, not the data, which is a transparency gap for a data-driven trial.
2.
HIGHdata code
Deposit de-identified participant data in a public repository (e.g., ClinicalStudyDataRequest, Vivli) with a DOI or accession number.
Repository deposit enhances reproducibility and is expected for clinical trials.
3.
HIGHstatistics
Reconcile the primary outcome confidence interval reported in the Abstract (0.38-2.39) with that in the Results (0.41,2.52) and ensure consistent reporting.
The discrepancy between the abstract and results could confuse readers and may indicate an error in one of the analyses.
4.
HIGHreporting
Temper the recommendation to simplify rehydration protocols and remove the distinction between SAM and non-malnourished children, as it goes beyond the direct evidence of the trial.
The trial found no difference in mortality, but the claim to change guidance is based on absence of harm and operational simplicity, which is an overstatement.
5.
MEDIUMreporting
Explicitly state adherence to a reporting guideline such as CONSORT in the Methods or provide a CONSORT flow diagram and checklist.
Explicit reporting guideline adherence improves transparency and is a common expectation for RCTs.
6.
MEDIUMethics
Name the specific ethics committees that approved the protocol and include protocol numbers.
Specific committee names and protocol numbers strengthen the ethics documentation.
7.
MEDIUMethics
State compliance with the Declaration of Helsinki or other regulatory framework.
Explicit regulatory compliance is a standard expectation for human research.
8.
MEDIUMdata code
Consider depositing the statistical analysis code in a public repository for reproducibility.
Sharing analysis code allows independent verification of the statistical methods.
9.
LOWcopyedit
Fix the typo in the Abstract: change 'Risk Ratio=1.02(9 CI 0.38-2.39)' to 'Risk Ratio=1.02 (95% CI 0.38-2.39)'.
The missing '5' in '95% CI' and inconsistent spacing are minor but should be corrected.
10.
LOWcopyedit
Complete the incomplete sentence in Methods, Trial Design and Oversight: 'detailed in .'
The placeholder should be replaced with a reference or removed.
11.
LOWcopyedit
Remove the extra space before the parenthesis in Methods, Trial Population: 'with at least bilateral pedal edema )'.
Minor formatting issue.
12.
LOWcopyedit
Use consistent symbols for footnotes in Table 2, replacing the unusual '¥' with standard symbols.
Consistent footnote symbols improve readability.
13.
LOWcopyedit
Ensure consistent use of comma vs. period in CI ranges across the manuscript.
The abstract uses 0.38-2.39 while results use 0.41,2.52; consistency is needed.

Full text (36,131 chars)Analyzed: Aug 15, 2026

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Intravenous Rehydration for Severe Acute Malnutrition with Gastroenteritis.

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DOI

10.1056/NEJMoa2505752

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Record fingerprint

5d157da58ca325c11c18b18f62d97e3fa8dadc406435f1be58e858225cea71f8

Verify via API

Issued Aug 15, 2026Engine 7.39.0

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

Kaimen Rigor review

Kaimen Rigor reviewed

3.5 / 5

Adequate — real issues to address

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

IntegrityIntegrity concern−0.5★
ClaimsOverstated claim−0.5★
StatisticsPrinted percentage does not match its own count (capped) ×2−0.25★
ReportingData & code availability partially met−0.25★

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

Not verified in this report

No data or code availability links were detected to verify.

Biggest issues

01Printed percentage does not match its own count
mediumArithmeticrecomputedFull detail
45% does not match the reported count 58/126
“58/126(45%)”
02Printed percentage does not match its own count
mediumArithmeticrecomputedFull detail
9% does not match the reported count 11/138
“11/138 (9%)”
03Conclusion reaches beyond the evidence
mediumOverreachreviewer-assessedFull detail
Current guidance should be reviewed to consider simplifying rehydration protocols, removing the distinction between SAM and non-malnourished children.
“Given the findings of this study, in the absence of other data, we would suggest that current guidance be reviewed to consider simplifying rehydration protocols, removing the distinction in management between SAM and non-malnourished children, which would be…”
DiscussionFind in source

Findings by category

201ArithmeticNumerical inconsistencies 202OverreachOverstated conclusions 03AuthenticityNone found 104DisclosureReporting gaps 05AvailabilityNone found · partly checked 06Copyedit6 minor suggestions

Numerical inconsistencies

2 findings · worst medium

Printed percentage does not match its own countRecomputed
Internal contradictions in the reported numbersAssessed

Recomputed 4 tests: 4 consistent, 0 inconsistent; 4 via agent-written checks. 2 printed percentages that do not match their own count.

Overstated conclusions

2 findings · worst medium

Conclusions overstated beyond the evidenceAssessed
Conclusions only partially backed by the presented evidenceAssessed

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· 90% conf

The paper establishes a clear scientific premise by citing prior research and guidelines, and provides a logical rationale for the trial.

Evidence

paraphrase[Introduction, paragraph 1-3]

IntroductionFind in source

paraphrase[Introduction, paragraph 2-3]

“Although such guidance documents have been in place for over two decades, no prior or subsequent evidence has been provided to support these recommendations .”

PASSReviewer 2· 90% conf

The paper establishes a clear scientific premise by citing prior research, identifying gaps in evidence, and providing a logical rationale for the trial.

Evidence

paraphrase[Introduction, paragraph 1]

“Although such guidance documents have been in place for over two decades, no prior or subsequent evidence has been provided to support these recommendations.”

paraphrase[Introduction, last paragraph]

paraphrase[Introduction]

“The paper does not explicitly discuss limitations of prior studies, but the trial design (randomized, multicenter) addresses the lack of RCT evidence.”

Sub-criteria

controlsADEQUATE

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 clear randomization, blinding of laboratory assessments, and a pre-specified statistical analysis plan.

Evidence

MethodsFind in source

“Study staff were unblinded throughout; laboratory tests were assayed blinded.”

MethodsFind in source

paraphrase[Methods, Statistical Analysis]

PASSReviewer 2· 95% conf

The trial design is rigorous: randomization method and unit are described, power analysis is provided, inclusion/exclusion criteria are pre-specified, and the analysis population is defined.

Evidence

MethodsFind in source

paraphrase[Methods, Statistical Analysis]

MethodsFind in source

Sub-criteria

demographicsADEQUATE

sex reportedADEQUATE

sex justifiedN/A

age weight healthADEQUATE

housing conditionsN/A

species strain sourceN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Biological variables and demographics are well reported, including sex, age, weight, and clinical characteristics.

Evidence

“Sex - male | 62 (45%) | 64 (48%) | 28 (42%) | 36 (54%)”

Table 1Find in source

“Age months | 12 (9, 22) | 14 (9, 23) | 16 (9, 24) | 14 (9, 22)”

Table 1Find in source

“Weight (kg) | 5.3 (4.5, 6.1) | 5.2 (4.6, 6.1) | 5.0 (4.5, 6.1) | 5.3 (4.7, 6.1)”

Table 1Find in source

PASSReviewer 2· 90% conf

Biological variables are well reported: sex, age, weight, and health status are provided in baseline characteristics; demographics are detailed.

Evidence

“Sex - male | 62 (45%) | 64 (48%) | 28 (42%) | 36 (54%)”

Table 1Find in source

“Age months | 12 (9, 22) | 14 (9, 23) | 16 (9, 24) | 14 (9, 22)”

Table 1Find in source

“Severe hyponatremia (sodium <125 mmol/L) | 70/131 (53%) | 67/131 (51%) | 35/66 (53%) | 32/65 (49%)”

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· 90% conf

Ethical approvals and consent procedures are adequately reported.

Evidence

“The protocol was approved by the local ethics committees and is available at nejm.org (https://www.nejm.org/) .”

MethodsFind in source

PASSReviewer 2· 85% conf

Ethical approvals are adequately reported: the protocol was approved by local ethics committees, and informed consent procedures are described.

Evidence

paraphrase[Methods, Trial Design and Oversight]

“The protocol was approved by the local ethics committees and is available at nejm.org.”

MethodsFind in source

absence[Methods]

Regulatory compliance is not explicitly stated.

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· 90% conf

The investigational product (Ringer's Lactate) and oral rehydration solutions are identified, and statistical software is named.

Evidence

“liberal:rapid rehydration (WHO Plan C: 100 ml/kg Ringer’s Lactate over 3-6 hours according to age with boluses (20 ml/kg) for those with shock)”

MethodsFind in source

“all participants were simultaneously factorially randomized (1:1) either to ( Re hydration So lution for Mal nutrition (ReSoMal)) or WHO oral rehydration solution (ORS)”

MethodsFind in source

“Analyses used Stata v18.”

Statistical analysisFind in source

PASSReviewer 2· 90% conf

The investigational product (Ringer's Lactate) and oral rehydration solutions are adequately identified, and statistical software is named.

Evidence

MethodsFind in source

“Analyses used Stata v18.”

Statistical analysisFind in source

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· 90% conf

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

Evidence

Statistical analysisFind in source

“Adjusted Risk Ratio (aRR) (liberal vs. control) =1.02 (95% CI 0.41,2.52); p=0.69”

ResultsFind in source

“Mortality at 96 hours | 11/138 (8%) | 9/134 (7%) | 5/67 (7%) | 4/67 (6%) | 1.02 (0.41,2.52) ; p=0.69”

Table 3Find in source

PASSReviewer 2· 90% conf

Statistical methods are appropriate and well-described: tests are named, effect sizes with CIs are reported, and software is identified.

Evidence

Statistical analysisFind in source

“Adjusted Risk Ratio (aRR) (liberal vs. control) =1.02 (95% CI 0.41,2.52); p=0.69”

ResultsFind in source

“Mortality at 96 hours | 11/138 (8%) | 9/134 (7%) | 5/67 (7%) | 4/67 (6%) | 1.02 (0.41,2.52) ; p=0.69”

Table 3Find in source

Sub-criteria

code sharingN/A

accession numbersN/A

repository depositNOT REPORTED

data availability statementINADEQUATE

Per reviewer (2) — the votes behind the verdict

WARNReviewer 1· 80% conf

A data availability statement is present but vague, and no data or code repositories are mentioned.

Evidence

“The protocol was approved by the local ethics committees and is available at nejm.org (https://www.nejm.org/) .”

MethodsFind in source

absence[Full text]

No repository deposit is mentioned.

WARNReviewer 2· 80% conf

A data availability statement is present but vague, and no data repository or code is provided.

Evidence

absence[End of paper]

No data availability statement is present.

“The protocol was approved by the local ethics committees and is available at nejm.org (https://www.nejm.org/) .”

MethodsFind in source

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 trial is registered, methods are detailed, limitations are discussed, and conclusions are proportional.

Evidence

“GASTROSAM Current Controlled Trials number, ISRCTN76149273”

AbstractFind in source

Discussion ¶1Find in source

FundingFind in source

PASSReviewer 2· 90% conf

Reporting is transparent: trial registration is provided, limitations are discussed, conclusions are proportional, and funding/COI are disclosed.

Evidence

“GASTROSAM Current Controlled Trials number, ISRCTN76149273”

AbstractFind in source

“The key limitation of our trial was the much lower overall mortality (9%) than we predicted from two small studies, which reported mortality at hospital discharge or 28 days as 68-82%”

Discussion ¶1Find in source

FundingFind in source

Registered (1 ID: ISRCTN). No reporting guideline cited.

Broken references and links

None found · partly checked

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.

Nothing surfaced — but not everything feeding this category ran (missing: data/code link verification), so read this as a partial clean bill.

Checked 24 references by DOI: 19 verified — 5 no DOI (shown, not verified).

Copyediting

6 minor

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

No major wording or formatting errors. 6 minor suggestions below.

6 copyedit issues flagged: mostly consistency, typo, grammar.

Kaimen Rigor Action ItemsFinal pass before journal submission

1.
HIGHdata code
Add a clear data availability statement in the Methods or a dedicated section, specifying how de-identified participant data can be accessed (e.g., via a data access committee or repository) and any conditions.
The current statement only mentions the protocol availability, not the data, which is a transparency gap for a data-driven trial.
2.
HIGHdata code
Deposit de-identified participant data in a public repository (e.g., ClinicalStudyDataRequest, Vivli) with a DOI or accession number.
Repository deposit enhances reproducibility and is expected for clinical trials.
3.
HIGHstatistics
Reconcile the primary outcome confidence interval reported in the Abstract (0.38-2.39) with that in the Results (0.41,2.52) and ensure consistent reporting.
The discrepancy between the abstract and results could confuse readers and may indicate an error in one of the analyses.
4.
HIGHreporting
Temper the recommendation to simplify rehydration protocols and remove the distinction between SAM and non-malnourished children, as it goes beyond the direct evidence of the trial.
The trial found no difference in mortality, but the claim to change guidance is based on absence of harm and operational simplicity, which is an overstatement.
5.
MEDIUMreporting
Explicitly state adherence to a reporting guideline such as CONSORT in the Methods or provide a CONSORT flow diagram and checklist.
Explicit reporting guideline adherence improves transparency and is a common expectation for RCTs.
6.
MEDIUMethics
Name the specific ethics committees that approved the protocol and include protocol numbers.
Specific committee names and protocol numbers strengthen the ethics documentation.
7.
MEDIUMethics
State compliance with the Declaration of Helsinki or other regulatory framework.
Explicit regulatory compliance is a standard expectation for human research.
8.
MEDIUMdata code
Consider depositing the statistical analysis code in a public repository for reproducibility.
Sharing analysis code allows independent verification of the statistical methods.
9.
LOWcopyedit
Fix the typo in the Abstract: change 'Risk Ratio=1.02(9 CI 0.38-2.39)' to 'Risk Ratio=1.02 (95% CI 0.38-2.39)'.
The missing '5' in '95% CI' and inconsistent spacing are minor but should be corrected.
10.
LOWcopyedit
Complete the incomplete sentence in Methods, Trial Design and Oversight: 'detailed in .'
The placeholder should be replaced with a reference or removed.
11.
LOWcopyedit
Remove the extra space before the parenthesis in Methods, Trial Population: 'with at least bilateral pedal edema )'.
Minor formatting issue.
12.
LOWcopyedit
Use consistent symbols for footnotes in Table 2, replacing the unusual '¥' with standard symbols.
Consistent footnote symbols improve readability.
13.
LOWcopyedit
Ensure consistent use of comma vs. period in CI ranges across the manuscript.
The abstract uses 0.38-2.39 while results use 0.41,2.52; consistency is needed.

Full text (36,131 chars)Analyzed: Aug 15, 2026