Kaimen Rigor reviewed

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A Randomized Trial of Shunting for Idiopathic Normal-Pressure Hydrocephalus

Name: Kaimen Rigor review — A Randomized Trial of Shunting for Idiopathic Normal-Pressure Hydrocephalus
Item: A Randomized Trial of Shunting for Idiopathic Normal-Pressure Hydrocephalus
Rating: 59
Author: Alpha1

Luciano MG, Williams MA, Hamilton MG, Katzen HL, Dasher NA, Moghekar A, Hua J, Malm J, Eklund A, Alpert Abel N, Raslan AM, Elder BD, Savage JJ, Barrow DL, Shahlaie K, Jensen H, Zwimpfer TJ, Wollett J, Hanley DF, Holubkov R, PENS Trial Investigators and the Adult Hydrocephalus Clinical Research Network.

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Kaimen Rigor review — 4★ (Strong), 0 critical, 3 high issues for “A Randomized Trial of Shunting for Idiopathic Normal-Pressure Hydrocephalus”

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This rigor review was examined and confirmed by Alpha1 Editorial · August 10, 2026

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A Randomized Trial of Shunting for Idiopathic Normal-Pressure Hydrocephalus

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DOI

10.1056/nejmoa2503109

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Kaimen Rigor reviewed

Rigor-Reviewed Manuscript

A Randomized Trial of Shunting for Idiopathic Normal-Pressure Hydrocephalus

Paper source

A Randomized Trial of Shunting for Idiopathic Normal-Pressure Hydrocephalus

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Alpha1 Editorial

This rigor review was examined and confirmed by Alpha1 Editorial · August 10, 2026

Kaimen Rigor review

Kaimen Rigor reviewed

4 / 5

Strong — minor issues to address

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

ReportingData & code availability not met−0.5★
ReportingEthical approvals partially met−0.25★
ReportingKey resources partially met−0.25★

Model-reported confidence: moderateReviewer agreement: highEngine: 7.29.0Source: full text

Not verified in this report

The numeric-impossibility checks (GRIM/GRIMMER/DEBIT/SPRITE) did not run on this paper: the pass that reads its reported means did not complete. No reported mean was checked for arithmetic impossibility.

Biggest issues

01Data and code not shared
highDisclosurereviewer-assessedFull detail
No data availability statement is present in the paper. Although the trial is registered, the paper does not state where the data can be accessed, which is a significant transparency gap.

Findings by category

01ArithmeticNone found 102OverreachOverstated conclusions 03AuthenticityNone found 304DisclosureReporting gaps 05AvailabilityNone found 06Copyedit4 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 methodologically strong, well-powered, double-blind placebo-controlled RCT of shunt surgery for iNPH, with a clear scientific rationale, robust design, adequate biological-variable reporting, consistent recomputation of the 7 machine-checkable statistics, and transparent reporting of outcomes, limitations, funding, and COI. The main weaknesses are the complete absence of a data availability statement (a fail) and under-specification of the randomization method, analysis software, and an explicit regulatory-compliance framework (warn-level gaps).

Both reviewers were synthesized per dimension; they agreed on 7 of 8 statuses and diverged only on ethical approvals (warn vs pass), which I resolved to warn while preserving the pass-dissenter's evidence. Statistics verification covered only the 7 tests reported with test statistic + df or effect + CI — everything else (including 'NS' p-values) is unverified, not confirmed. No retracted or unresolvable references (44 checked); both reproducibility links are live; the trial is registered (ClinicalTrials.gov NCT05081128).

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; 7 via agent-written checks.

Overstated conclusions

1 finding · worst low

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 only partially backed by the presented evidenceAssessed

8 major claims checked against the paper's own evidence: all adequately supported.

Efficacy claim is anchored to an adequate endpoint and a meaningful effect.

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

3 findings · worst high

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 and code not sharedAssessed
Ethics/consent reporting incompleteAssessed
Key resources under-identified (antibodies, cell lines, RRIDs)Assessed

Eight Dimensions5 pass · 2 warn · 1 fail

The introduction cites the 2005 International iNPH Guidelines, the Japanese Guidelines, previous small trials, and a 2024 Cochrane review noting the need for larger studies. It acknowledges skepticism about shunt effectiveness and a call for a moratorium. The study objectives directly follow from these gaps.

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The paper clearly establishes the scientific premise, cites prior studies and guidelines, and justifies the need for an adequately powered randomized placebo-controlled trial.

Evidence

“a 2024 Cochrane review noted, “there is a need for similar studies to increase the certainty of the findings presented””

IntroductionFind in source

“The effectiveness of shunting is questioned due to the absence of adequately powered, randomized trials.”

AbstractFind in source

“This is an international, multi-center, prospective, double-blind, randomized, placebo-controlled trial.”

MethodsFind in source

PASSReviewer 2· 95% conf

The paper clearly establishes the scientific foundation by citing prior research, providing a logical rationale, and addressing limitations of prior work.

Evidence

paraphrase[Introduction, paragraph 2]

“The 2005 International iNPH Guidelines and the Japanese Guidelines standardized patient selection for shunt surgery... Three small-sample randomized placebo-controlled trials suggested that shunt surgery was effective, but a 2024 Cochrane review noted, 'there is a need for similar studies to increase the certainty of the findings presented'.”

“the clinical effectiveness of shunt surgery for iNPH has been subject to skepticism to the point of a call for a moratorium on shunt surgery because of variability of study results, questionable durability of benefit, the risks of surgery, and the potential for a strong placebo effect.”

Introduction ¶2Find in source

“The effectiveness of shunting is questioned due to the absence of adequately powered, randomized trials.”

AbstractFind in source

The trial is described as double-blind, randomized, placebo-controlled. Randomization occurred in a 1:1 ratio but the specific method (e.g., computer-generated) is not stated. Blinding of participants and personnel except shunt adjusters is described. A priori power analysis (>90% power for 0.2 m/s difference) is provided. Inclusion/exclusion criteria are detailed. Missing data are handled via multiple imputation, and per-protocol and as-treated analyses are performed. Control is via placebo setting. Independent replication is not applicable for a single pivotal trial.

Sub-criteria

controlsN/A

power analysisADEQUATE

blinding levelsADEQUATE

outlier handlingADEQUATE

randomization unitADEQUATE

inclusion exclusionADEQUATE

randomization methodINADEQUATE

replicate distinctionN/A

independent replicationN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 75% conf

Core design elements are strong: 1:1 randomization, double-blind placebo control, sample size calculation, and prespecified inclusion/exclusion criteria; however, the randomization method itself is not described.

Evidence

“Randomization occurred immediately before surgery in a 1:1 ratio.”

MethodsFind in source

“Treatment assignments were concealed from study participants and personnel, except for investigators responsible for shunt adjustments, and were disclosed only for patient safety reasons.”

MethodsFind in source

“A sample size of 100 participants was specified, providing >90% power to detect a between group gait velocity difference of 0.2 m/s (SD=0.29 m/s), accounting for interim analyses and attrition.”

Statistical analysisFind in source

PASSReviewer 2· 90% conf

The study design is robust with blinding, power analysis, inclusion/exclusion criteria, and appropriate handling of missing data and protocol deviations. The randomization method is not fully described, but this is a minor gap.

Evidence

“Randomization occurred immediately before surgery in a 1:1 ratio.”

Methods ¶3Find in source

“Treatment assignments were concealed from study participants and personnel, except for investigators responsible for shunt adjustments, and were disclosed only for patient safety reasons.”

Methods ¶3Find in source

“A sample size of 100 participants was specified, providing >90% power to detect a between group gait velocity difference of 0.2 m/s (SD=0.29 m/s), accounting for interim analyses and attrition.”

Statistical analysisFind in source

Table 1 presents sex (48.5% female, 51.5% male), age (mean 75.0 ± 5.7 years), race, ethnicity, education, and comorbidities (Table 2). The study includes both sexes, so a single-sex justification is not needed. Age and health status are adequately reported. Demographics are comprehensive.

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 and demographic variables relevant to a human trial are reported adequately, including sex, age, comorbidities, race, ethnicity, and educational attainment.

Evidence

“Participants were 51.5% male and 48.5% female, with mean age 75.0 ± 5.7 years, and 63% with a Bachelor’s degree or higher.”

ResultsFind in source

“Any comorbidities | 46 (92.0%) | 33 (67.3%) | 79 (79.8%)”

Table 2Find in source

paraphrase[Table 1]

“Table 1 reports ethnicity, race, sex, educational attainment, and country for each treatment group.”

PASSReviewer 2· 95% conf

Sex, age, and detailed demographics are reported in Table 1. Both sexes are included, so sex justification is not required. Health status is captured through comorbidities. Species/strain and housing are not applicable for a human study.

Evidence

“Participants were 51.5% male and 48.5% female”

Table 1Find in source

“mean age 75.0 ± 5.7 years”

Table 1Find in source

paraphrase[Results, Table 1]

“Race: White 90.9%, Asian 5.1%, Black or African American 3.0%... Educational Attainment: Bachelor's degree or higher 63%”

IRB approval is adequately reported with a protocol identifier. Consent is reported as obtained. However, the paper does not state adherence to the Declaration of Helsinki, ICH-GCP, or the Common Rule, so the regulatory_compliance sub-criterion is not met.

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceNOT REPORTED

Per reviewer (2) — the votes behind the verdict

WARNReviewer 1· 65% conf

Named IRB approval and consent are reported, but no explicit regulatory-compliance statement mentioning a recognized framework is present.

Evidence

“For U.S. sites, the central Institutional Review Board (IRB) was at Johns Hopkins Medicine (IRB00305245), with local IRBs at the Canadian and Swedish sites.”

MethodsFind in source

“125 (53%) provided consent and 99 were randomized”

ResultsFind in source

absence[Methods]

No regulatory framework is named

PASSReviewer 2· 90% conf

The study reports a named IRB with a protocol number, mentions consent, and implies regulatory compliance through IRB approval. No explicit statement of compliance with the Declaration of Helsinki is made, but IRB approval suffices for human research.

Evidence

“For U.S. sites, the central Institutional Review Board (IRB) was at Johns Hopkins Medicine (IRB00305245), with local IRBs at the Canadian and Swedish sites.”

Methods ¶2Find in source

“Of 237 approached for the study, 125 (53%) provided consent”

Results ¶1Find in source

paraphrase[Methods, paragraph 2]

“The study obtained IRB approval from multiple institutions, indicating compliance with local regulations.”

The shunt valve is identified by name, manufacturer, and location: 'Codman Certas Plus with SiphonGuard®, Integra LifeSciences, Princeton, NJ'. However, the statistical software (e.g., SAS, R) and the MRI analysis software are not named. No other biological resources (antibodies, cell lines, etc.) are used, so those are not applicable.

Sub-criteria

mycoplasma testingN/A

reagents identifiedADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedNOT REPORTED

Per reviewer (2) — the votes behind the verdict

WARNReviewer 1· 70% conf

The investigational device is fully identified, but the deep-learning brain extraction tool used in image analysis is not identified by name/version, and statistical software is not identified.

Evidence

“The study intervention was the initial setting of a commercially available noninvasively adjustable shunt valve (Codman Certas Plus with SiphonGuard ® , Integra LifeSciences, Princeton, NJ)”

MethodsFind in source

“MRI evaluation of lateral ventricular volume and the Evans ratio was performed on de-identified T1 images using segmentation from spatially localized atlas network tiles and a deep-learning “brain extraction tool”.”

MethodsFind in source

absence[Methods, Statistical Analysis]

Statistical software is not identified

WARNReviewer 2· 80% conf

The investigational product (shunt valve) is well identified, but the software used for analysis is not reported. This is a common gap in clinical trial reports.

Evidence

paraphrase[Methods, paragraph 1]

“Codman Certas Plus with SiphonGuard®, Integra LifeSciences, Princeton, NJ”

absence[Methods, Statistical Analysis]

Statistical software is not identified.

The primary analysis uses linear regression with adjustment for covariates. Tests are named (linear regression, Fisher's exact test). Exact p-values are given for the primary outcome (P<0.001) and secondary outcomes (P=0.003). Effect sizes with 95% CIs are reported for all outcomes. Data presentation includes tables with means, SDs, and per-group n, and a figure showing individual data points. Assumptions are not explicitly tested, but the use of robust methods is acceptable for a clinical trial. Mathematical plausibility checks confirmed no obvious errors.

Sub-criteria

tests namedADEQUATE

exact p valuesADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedNOT REPORTED

assumptions verifiedADEQUATE

mathematical plausibilityPASS

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 70% conf

Statistical methods are generally well described with named tests, CIs, and imputation approaches; however, no statistical software is identified and exact P values are missing for some secondary outcomes.

Evidence

“Three-month outcomes were analyzed using linear regression with treatment arm as the predictor, adjusting for baseline values and prespecified covariates”

Statistical analysisFind in source

“Gait Velocity (m/s) | 0.82 ± 0.27 | 0.87 ± 0.25 | 0.03 ± 0.23 | 0.23 ± 0.23 | 0.21 (0.12, 0.31) | <0.001”

Table 3Find in source

“MoCA | 20.8 ± 4.1 | 21.4 ± 4.0 | 0.3 ± 2.9 | 1.3 ± 2.1 | 1.2 (0.1, 2.2) | NS”

Table 3Find in source

PASSReviewer 2· 85% conf

Statistical tests are named, exact p-values are reported for the primary and secondary outcomes (with Bonferroni-Holm correction), effect sizes with confidence intervals are provided, and data presentation is adequate. The statistical software is not identified, which is a minor reporting gap.

Evidence

paraphrase[Results, Table 3]

“Gait Velocity: treatment difference 0.21 (0.12, 0.31) P<0.001; Tinetti: 3.1 (1.0, 5.1) P=0.003”

paraphrase[Results, Table 3]

“Treatment Difference (95% CI) column present for all outcomes”

absence[Methods, Statistical Analysis]

Statistical software is not identified.

The paper does not include a data availability statement. There is no mention of a repository deposit, accession numbers, or a mechanism for requesting data. Code sharing is not applicable as no custom code is described. Given that this is a clinical trial, the absence of a data availability statement is a notable omission.

Sub-criteria

code sharingN/A

accession numbersN/A

repository depositN/A

data availability statementNOT REPORTED

Per reviewer (2) — the votes behind the verdict

FAILReviewer 1· 85% conf

The paper presents no data availability statement, no data-sharing plan, and no repository or code links.

Evidence

absence[Whole manuscript]

No data availability statement is present

“Trial registration number: PENS ClinicalTrials.gov (http://ClinicalTrials.gov) number, NCT05081128”

AbstractFind in source

FAILReviewer 2· 90% conf

No data availability statement is present in the paper. Although the trial is registered, the paper does not state where the data can be accessed, which is a significant transparency gap.

Evidence

absence[Entire manuscript]

No data availability statement is present.

Methods are described in sufficient detail. The trial is registered (NCT05081128). All pre-specified outcomes are reported, including negative results (MoCA, OABQsf). Limitations are discussed in a dedicated section. Conclusions are proportional to the evidence. Funding sources and conflicts of interest are disclosed. No reporting checklist is referenced, but the paper follows CONSORT-like structure.

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineNOT REPORTED

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 80% conf

The manuscript is transparent about methods, outcomes, limitations, funding, and conflicts of interest; the main gap is the absence of a referenced reporting guideline (e.g., CONSORT).

Evidence

“Trial registration number: PENS ClinicalTrials.gov (http://ClinicalTrials.gov) number, NCT05081128”

AbstractFind in source

“The major strengths of the study include its blinded design, statistical power, rigorous training of clinical assessors, and quality control procedures.”

LimitationsFind in source

absence[Whole manuscript]

No CONSORT or other reporting guideline is referenced

PASSReviewer 2· 90% conf

The manuscript is comprehensive, with detailed methods, trial registration, reporting of all outcomes, limitations discussion, proportional conclusions, and funding/COI statements. The only gap is the absence of a reference to a reporting guideline (e.g., CONSORT).

Evidence

paraphrase[Abstract, Methods]

“Trial registration number: PENS ClinicalTrials.gov number, NCT05081128”

paraphrase[Funding section]

“The study was funded by the NINDS U01NS122764; Disclosure forms provided by the authors are available”

“A potential limitation is the 3-month primary timepoint, which is standard for iNPH research. This study does not yet address the long-term outcomes.”

LimitationsFind in source

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

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: 39 verified — 5 no DOI (shown, not verified).

2 data/code links checked; 2 live.

Copyediting

4 minor

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

No major wording or formatting errors. 4 minor suggestions below.

4 copyedit issues flagged: mostly consistency, other, grammar.

Kaimen Rigor Action ItemsFinal pass before journal submission

In this post-publication audit, the published trial is robust in design, power, and transparency, and all 7 recomputable statistics are consistent; an informed reader should weigh the absence of a data availability statement and the incomplete identification of randomization method and software as the most substantive gaps. The missing explicit Helsinki/GCP compliance statement is a minor reporting gap that would warrant a small correction only if the authors wish to state the governing framework. No retracted citations, dead links, or statistical inconsistencies were found, so none of these gaps undermines the core conclusions.

1.
HIGHdata code
Add a data availability statement specifying a concrete managed-access route (e.g., de-identified individual participant data available on request to the corresponding author or via a data-access committee, with conditions and timeframe) and note it in a published correction.
The complete absence of a data availability statement is the single fail dimension and a significant transparency gap for a clinical trial.
2.
HIGHrigor
Describe the randomization method in the Randomization/Blinding subsection (e.g., central web-based system, block sizes, stratification variables) — currently only '1:1 ratio' is stated.
Both reviewers flagged the missing randomization mechanism as a reporting gap that an informed reader cannot verify allocation concealment integrity without.
3.
HIGHrigor
Identify the statistical software (name and version, e.g., SAS or R) used for all analyses in the Statistical Analysis section.
Both reviewers noted the analysis software is unnamed, which hampers reproducibility of the computations.
4.
MEDIUMrigor
Identify the deep-learning 'brain extraction tool' used for MRI segmentation by name and version (or RRID) in the Outcome Measures section.
The MRI analysis pipeline is under-specified, which limits reproducibility of the imaging-derived outcomes (ventricular volume, Evans ratio).
5.
MEDIUMethics
Add an explicit regulatory-compliance statement naming the governing framework (Declaration of Helsinki and/or ICH-GCP) in the Ethics/Approvals section, or confirm in a correction that the listed IRB approvals constitute the compliance statement.
An explicit framework statement is currently absent; Reviewer 1 scored this as a warn-level gap while Reviewer 2 considered IRB approval sufficient, so a one-line clarification resolves the ambiguity.
6.
MEDIUMstatistics
Report exact P values for MoCA and OABQsf in Table 3, or explicitly state that these outcomes are reported by effect estimate and CI without hypothesis testing.
Two secondary outcomes are shown only as 'NS', which is imprecise reporting the copyedit pass also flagged.
7.
MEDIUMreporting
Reference the CONSORT reporting checklist (in Methods or supplementary material) to document reporting completeness.
Both reviewers noted no reporting guideline is cited, which is expected for a published RCT.
8.
MEDIUMcopyedit
Remove the template placeholder text 'Click or tap here to enter text.' from the Figure 1 legend.
This is a visible template artifact in the published figure legend that should be corrected.
9.
LOWcopyedit
Correct the grammatical error in Methods, Statistical Analysis: 'controlling for treatment arm as the predictors' → 'as the predictor'.
Singular/plural disagreement flagged by the copyedit pass.
10.
LOWcopyedit
Capitalize the Table 1 header 'Assigned treatment group' consistently (e.g., 'Assigned Treatment Group').
Minor capitalization inconsistency flagged by the copyedit pass.

Full text (33,648 chars)Analyzed: Aug 10, 2026

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A Randomized Trial of Shunting for Idiopathic Normal-Pressure Hydrocephalus

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DOI

10.1056/nejmoa2503109

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d066fa43dc70f6c53b9d89dda2d2bbb7e174c6cce6c4b5ebfcfc97f0ccf52ac1

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Issued Aug 10, 2026Engine 7.29.0

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

Kaimen Rigor review

Kaimen Rigor reviewed

4 / 5

Strong — minor issues to address

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

ReportingData & code availability not met−0.5★
ReportingEthical approvals partially met−0.25★
ReportingKey resources partially met−0.25★

Model-reported confidence: moderateReviewer agreement: highEngine: 7.29.0Source: full text

Not verified in this report

The numeric-impossibility checks (GRIM/GRIMMER/DEBIT/SPRITE) did not run on this paper: the pass that reads its reported means did not complete. No reported mean was checked for arithmetic impossibility.

Biggest issues

01Data and code not shared
highDisclosurereviewer-assessedFull detail
No data availability statement is present in the paper. Although the trial is registered, the paper does not state where the data can be accessed, which is a significant transparency gap.

Findings by category

01ArithmeticNone found 102OverreachOverstated conclusions 03AuthenticityNone found 304DisclosureReporting gaps 05AvailabilityNone found 06Copyedit4 minor suggestions

Numerical inconsistencies

None found

Checked — nothing surfaced.

Recomputed 7 tests: 7 consistent, 0 inconsistent; 7 via agent-written checks.

Overstated conclusions

1 finding · worst low

Conclusions only partially backed by the presented evidenceAssessed

8 major claims checked against the paper's own evidence: all adequately supported.

Efficacy claim is anchored to an adequate endpoint and a meaningful effect.

Data authenticity concerns

None found

Checked — nothing surfaced.

Reporting gaps

3 findings · worst high

Data and code not sharedAssessed
Ethics/consent reporting incompleteAssessed
Key resources under-identified (antibodies, cell lines, RRIDs)Assessed

Eight Dimensions5 pass · 2 warn · 1 fail

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The paper clearly establishes the scientific premise, cites prior studies and guidelines, and justifies the need for an adequately powered randomized placebo-controlled trial.

Evidence

“a 2024 Cochrane review noted, “there is a need for similar studies to increase the certainty of the findings presented””

IntroductionFind in source

“The effectiveness of shunting is questioned due to the absence of adequately powered, randomized trials.”

AbstractFind in source

“This is an international, multi-center, prospective, double-blind, randomized, placebo-controlled trial.”

MethodsFind in source

PASSReviewer 2· 95% conf

The paper clearly establishes the scientific foundation by citing prior research, providing a logical rationale, and addressing limitations of prior work.

Evidence

paraphrase[Introduction, paragraph 2]

Introduction ¶2Find in source

“The effectiveness of shunting is questioned due to the absence of adequately powered, randomized trials.”

AbstractFind in source

Sub-criteria

controlsN/A

power analysisADEQUATE

blinding levelsADEQUATE

outlier handlingADEQUATE

randomization unitADEQUATE

inclusion exclusionADEQUATE

randomization methodINADEQUATE

replicate distinctionN/A

independent replicationN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 75% conf

Evidence

“Randomization occurred immediately before surgery in a 1:1 ratio.”

MethodsFind in source

“Treatment assignments were concealed from study participants and personnel, except for investigators responsible for shunt adjustments, and were disclosed only for patient safety reasons.”

MethodsFind in source

“A sample size of 100 participants was specified, providing >90% power to detect a between group gait velocity difference of 0.2 m/s (SD=0.29 m/s), accounting for interim analyses and attrition.”

Statistical analysisFind in source

PASSReviewer 2· 90% conf

Evidence

“Randomization occurred immediately before surgery in a 1:1 ratio.”

Methods ¶3Find in source

“Treatment assignments were concealed from study participants and personnel, except for investigators responsible for shunt adjustments, and were disclosed only for patient safety reasons.”

Methods ¶3Find in source

“A sample size of 100 participants was specified, providing >90% power to detect a between group gait velocity difference of 0.2 m/s (SD=0.29 m/s), accounting for interim analyses and attrition.”

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· 90% conf

Biological and demographic variables relevant to a human trial are reported adequately, including sex, age, comorbidities, race, ethnicity, and educational attainment.

Evidence

“Participants were 51.5% male and 48.5% female, with mean age 75.0 ± 5.7 years, and 63% with a Bachelor’s degree or higher.”

ResultsFind in source

“Any comorbidities | 46 (92.0%) | 33 (67.3%) | 79 (79.8%)”

Table 2Find in source

paraphrase[Table 1]

“Table 1 reports ethnicity, race, sex, educational attainment, and country for each treatment group.”

PASSReviewer 2· 95% conf

Evidence

“Participants were 51.5% male and 48.5% female”

Table 1Find in source

“mean age 75.0 ± 5.7 years”

Table 1Find in source

paraphrase[Results, Table 1]

“Race: White 90.9%, Asian 5.1%, Black or African American 3.0%... Educational Attainment: Bachelor's degree or higher 63%”

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceNOT REPORTED

Per reviewer (2) — the votes behind the verdict

WARNReviewer 1· 65% conf

Named IRB approval and consent are reported, but no explicit regulatory-compliance statement mentioning a recognized framework is present.

Evidence

“For U.S. sites, the central Institutional Review Board (IRB) was at Johns Hopkins Medicine (IRB00305245), with local IRBs at the Canadian and Swedish sites.”

MethodsFind in source

“125 (53%) provided consent and 99 were randomized”

ResultsFind in source

absence[Methods]

No regulatory framework is named

PASSReviewer 2· 90% conf

Evidence

“For U.S. sites, the central Institutional Review Board (IRB) was at Johns Hopkins Medicine (IRB00305245), with local IRBs at the Canadian and Swedish sites.”

Methods ¶2Find in source

“Of 237 approached for the study, 125 (53%) provided consent”

Results ¶1Find in source

paraphrase[Methods, paragraph 2]

“The study obtained IRB approval from multiple institutions, indicating compliance with local regulations.”

Sub-criteria

mycoplasma testingN/A

reagents identifiedADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedNOT REPORTED

Per reviewer (2) — the votes behind the verdict

WARNReviewer 1· 70% conf

The investigational device is fully identified, but the deep-learning brain extraction tool used in image analysis is not identified by name/version, and statistical software is not identified.

Evidence

“The study intervention was the initial setting of a commercially available noninvasively adjustable shunt valve (Codman Certas Plus with SiphonGuard ® , Integra LifeSciences, Princeton, NJ)”

MethodsFind in source

absence[Methods, Statistical Analysis]

Statistical software is not identified

WARNReviewer 2· 80% conf

The investigational product (shunt valve) is well identified, but the software used for analysis is not reported. This is a common gap in clinical trial reports.

Evidence

paraphrase[Methods, paragraph 1]

“Codman Certas Plus with SiphonGuard®, Integra LifeSciences, Princeton, NJ”

absence[Methods, Statistical Analysis]

Statistical software is not identified.

Sub-criteria

tests namedADEQUATE

exact p valuesADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedNOT REPORTED

assumptions verifiedADEQUATE

mathematical plausibilityPASS

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 70% conf

Evidence

“Three-month outcomes were analyzed using linear regression with treatment arm as the predictor, adjusting for baseline values and prespecified covariates”

Statistical analysisFind in source

“Gait Velocity (m/s) | 0.82 ± 0.27 | 0.87 ± 0.25 | 0.03 ± 0.23 | 0.23 ± 0.23 | 0.21 (0.12, 0.31) | <0.001”

Table 3Find in source

“MoCA | 20.8 ± 4.1 | 21.4 ± 4.0 | 0.3 ± 2.9 | 1.3 ± 2.1 | 1.2 (0.1, 2.2) | NS”

Table 3Find in source

PASSReviewer 2· 85% conf

Evidence

paraphrase[Results, Table 3]

“Gait Velocity: treatment difference 0.21 (0.12, 0.31) P<0.001; Tinetti: 3.1 (1.0, 5.1) P=0.003”

paraphrase[Results, Table 3]

“Treatment Difference (95% CI) column present for all outcomes”

absence[Methods, Statistical Analysis]

Statistical software is not identified.

Sub-criteria

code sharingN/A

accession numbersN/A

repository depositN/A

data availability statementNOT REPORTED

Per reviewer (2) — the votes behind the verdict

FAILReviewer 1· 85% conf

The paper presents no data availability statement, no data-sharing plan, and no repository or code links.

Evidence

absence[Whole manuscript]

No data availability statement is present

“Trial registration number: PENS ClinicalTrials.gov (http://ClinicalTrials.gov) number, NCT05081128”

AbstractFind in source

FAILReviewer 2· 90% conf

No data availability statement is present in the paper. Although the trial is registered, the paper does not state where the data can be accessed, which is a significant transparency gap.

Evidence

absence[Entire manuscript]

No data availability statement is present.

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineNOT REPORTED

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 80% conf

The manuscript is transparent about methods, outcomes, limitations, funding, and conflicts of interest; the main gap is the absence of a referenced reporting guideline (e.g., CONSORT).

Evidence

“Trial registration number: PENS ClinicalTrials.gov (http://ClinicalTrials.gov) number, NCT05081128”

AbstractFind in source

“The major strengths of the study include its blinded design, statistical power, rigorous training of clinical assessors, and quality control procedures.”

LimitationsFind in source

absence[Whole manuscript]

No CONSORT or other reporting guideline is referenced

PASSReviewer 2· 90% conf

Evidence

paraphrase[Abstract, Methods]

“Trial registration number: PENS ClinicalTrials.gov number, NCT05081128”

paraphrase[Funding section]

“The study was funded by the NINDS U01NS122764; Disclosure forms provided by the authors are available”

“A potential limitation is the 3-month primary timepoint, which is standard for iNPH research. This study does not yet address the long-term outcomes.”

LimitationsFind in source

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

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: 39 verified — 5 no DOI (shown, not verified).

2 data/code links checked; 2 live.

Copyediting

4 minor

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

No major wording or formatting errors. 4 minor suggestions below.

4 copyedit issues flagged: mostly consistency, other, grammar.

Kaimen Rigor Action ItemsFinal pass before journal submission

1.
HIGHdata code
Add a data availability statement specifying a concrete managed-access route (e.g., de-identified individual participant data available on request to the corresponding author or via a data-access committee, with conditions and timeframe) and note it in a published correction.
The complete absence of a data availability statement is the single fail dimension and a significant transparency gap for a clinical trial.
2.
HIGHrigor
Describe the randomization method in the Randomization/Blinding subsection (e.g., central web-based system, block sizes, stratification variables) — currently only '1:1 ratio' is stated.
Both reviewers flagged the missing randomization mechanism as a reporting gap that an informed reader cannot verify allocation concealment integrity without.
3.
HIGHrigor
Identify the statistical software (name and version, e.g., SAS or R) used for all analyses in the Statistical Analysis section.
Both reviewers noted the analysis software is unnamed, which hampers reproducibility of the computations.
4.
MEDIUMrigor
Identify the deep-learning 'brain extraction tool' used for MRI segmentation by name and version (or RRID) in the Outcome Measures section.
The MRI analysis pipeline is under-specified, which limits reproducibility of the imaging-derived outcomes (ventricular volume, Evans ratio).
5.
MEDIUMethics
Add an explicit regulatory-compliance statement naming the governing framework (Declaration of Helsinki and/or ICH-GCP) in the Ethics/Approvals section, or confirm in a correction that the listed IRB approvals constitute the compliance statement.
An explicit framework statement is currently absent; Reviewer 1 scored this as a warn-level gap while Reviewer 2 considered IRB approval sufficient, so a one-line clarification resolves the ambiguity.
6.
MEDIUMstatistics
Report exact P values for MoCA and OABQsf in Table 3, or explicitly state that these outcomes are reported by effect estimate and CI without hypothesis testing.
Two secondary outcomes are shown only as 'NS', which is imprecise reporting the copyedit pass also flagged.
7.
MEDIUMreporting
Reference the CONSORT reporting checklist (in Methods or supplementary material) to document reporting completeness.
Both reviewers noted no reporting guideline is cited, which is expected for a published RCT.
8.
MEDIUMcopyedit
Remove the template placeholder text 'Click or tap here to enter text.' from the Figure 1 legend.
This is a visible template artifact in the published figure legend that should be corrected.
9.
LOWcopyedit
Correct the grammatical error in Methods, Statistical Analysis: 'controlling for treatment arm as the predictors' → 'as the predictor'.
Singular/plural disagreement flagged by the copyedit pass.
10.
LOWcopyedit
Capitalize the Table 1 header 'Assigned treatment group' consistently (e.g., 'Assigned Treatment Group').
Minor capitalization inconsistency flagged by the copyedit pass.

Full text (33,648 chars)Analyzed: Aug 10, 2026