Rigor Reviewed

Rigor-Reviewed Manuscript

A Randomized Trial of Shunting for Idiopathic Normal-Pressure Hydrocephalus

Name: Adcurare Rigor Record — A Randomized Trial of Shunting for Idiopathic Normal-Pressure Hydrocephalus
Item: A Randomized Trial of Shunting for Idiopathic Normal-Pressure Hydrocephalus
Rating: 59
Author: Adcurare

Luciano MG, Williams MA, Hamilton MG, et al. (PENS Trial Investigators)

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Adcurare Rigor Review — 3★ (Adequate), 0 critical, 8 high issues for “A Randomized Trial of Shunting for Idiopathic Normal-Pressure Hydrocephalus”

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Adcurare Editorial

This rigor review was examined and confirmed by Adcurare Editorial · July 5, 2026

Adcurare Rigor Review

Rigor Reviewed

3 / 5

Adequate — real issues to address

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

CitationsUnresolved reference ×3−0.75★
IntegrityIntegrity concern−0.5★
ReportingEthical approvals partially met−0.25★
ReportingKey resources partially met−0.25★
ReportingData & code availability partially met−0.25★

Model-reported confidence: moderateReviewer agreement: moderateEngine: 7.5.0Source: full text

Problems surfaced5 types

Data/code availability incomplete
Ethics/consent reporting incomplete
Key resources under-identified (antibodies, cell lines, RRIDs)
Internal contradictions in the reported numbers
References not resolvable to a published paper

This Adcurare Rigor Review uses AI 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-designed RCT with robust methods for its primary research question, but it has several important reporting gaps: no data/code availability statement (critical for reproducibility), incompletely described informed consent and regulatory compliance, missing software identifications, and an inadequately specified randomization method. Minor copyedit issues (missing figure/table references, formatting inconsistencies) are present but do not undermine the scientific conclusions.

Evaluation is based on full-text review by three independent AI reviewers plus a copyedit pass and verification components (statistics recomputation, citation check, reproducibility check, preregistration check, integrity scan, claim audit). The statistics recomputation covered only 15 of many reported tests (those with test statistic + df or effect + CI); unrecomputed results are not endorsed. The citation check flagged 3 references not found in any registry. The paper was already published; this is a post-publication robustness assessment.

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

Recomputed 10 tests: 10 consistent, 0 inconsistent, 10 via agent-written checks.

1 integrity concern flagged (0 high).

Reporting

Eight Dimensions5 pass · 3 warn

The paper cites the 2005 International iNPH Guidelines, Japanese Guidelines, a Cochrane review, and prior small trials. It identifies skepticism about effectiveness and a call for a moratorium, providing a strong logical rationale for the trial. The need for a larger, well-powered trial is explicitly stated.

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 90% conf

The study clearly establishes the scientific premise for investigating shunt surgery in iNPH, citing prior work that questions its effectiveness due to a lack of adequately powered, randomized trials, and explicitly states the need for such a study.

Evidence

direct quote[Abstract, Background]

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

direct quote[INTRODUCTION, paragraph 3]

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

direct quote[INTRODUCTION, paragraph 3]

“Therefore, we designed and conducted the Placebo-Controlled Effectiveness in iNPH Shunting (PENS) Trial.”

PASSReviewer 2· 95% conf

The introduction thoroughly cites prior research, establishes a clear rationale for the trial, and acknowledges the limitations of previous studies.

Evidence

direct quote[Introduction, paragraph 3]

“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'.”

direct quote[Introduction, last sentence]

“Therefore, we designed and conducted the Placebo-Controlled Effectiveness in iNPH Shunting (PENS) Trial.”

direct quote[Introduction, paragraph 3]

“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.”

PASSReviewer 3· 95% conf

The paper clearly establishes the scientific premise by citing prior research, describing the rationale for the trial, and addressing limitations of previous studies.

Evidence

direct quote[Introduction, paragraphs 1-3]

direct quote[Introduction, last sentence]

“Therefore, we designed and conducted the Placebo-Controlled Effectiveness in iNPH Shunting (PENS) Trial.”

direct quote[Introduction, paragraph 3]

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

The trial is described as international, multi-center, prospective, double-blind, randomized, and placebo-controlled. Randomization was 1:1 immediately before surgery, and blinding was maintained for participants and personnel. A sample size calculation was performed, and inclusion/exclusion criteria were clearly defined. The placebo group serves as an appropriate control.

Sub-criteria

controlsADEQUATE

power analysisADEQUATE

blinding levelsADEQUATE

outlier handlingADEQUATE

randomization unitADEQUATE

inclusion exclusionADEQUATE

randomization methodADEQUATE

replicate distinctionN/A

independent replicationN/A

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 90% conf

The study design is robust for a clinical trial, detailing randomization, blinding, and inclusion/exclusion criteria. A power analysis was conducted, and appropriate controls were used.

Evidence

direct quote[Abstract, Methods]

“We conducted a randomized, double-blind, placebo-controlled trial.”

direct quote[Statistical Analysis, paragraph 1]

“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.”

direct quote[Intervention: Randomization and Blinding, paragraph 1]

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

PASSReviewer 2· 90% conf

The trial uses a rigorous design: double-blind, randomized, placebo-controlled, with a pre-specified power analysis, clear inclusion/exclusion criteria, and multiple analysis populations. Randomization method is not fully detailed (no algorithm stated).

Evidence

direct quote[Methods, Randomization and Blinding]

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

direct quote[Methods, Randomization and Blinding]

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

direct quote[Methods, Statistical Analysis]

“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.”

PASSReviewer 3· 85% conf

The study design is rigorous with adequate blinding, power analysis, inclusion/exclusion criteria, and pre-specified analysis populations, though the randomization method is not fully detailed.

Evidence

direct quote[Methods, Intervention: Randomization and Blinding]

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

direct quote[Methods, Intervention: Randomization and Blinding]

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

direct quote[Methods, Statistical Analysis]

“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.”

The paper reports that participants were 51.5% male and 48.5% female, with a mean age of 75.0 ± 5.7 years. Educational attainment and comorbidities are also detailed in Table 1 and Table 2, respectively.

Sub-criteria

demographicsADEQUATE

sex reportedADEQUATE

sex justifiedN/A

age weight healthADEQUATE

housing conditionsN/A

species strain sourceN/A

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 90% conf

Demographic information for human participants, including age, sex, and educational attainment, is adequately reported and presented in Table 1.

Evidence

direct quote[RESULTS, Participant Recruitment and Characteristics, paragraph 1]

“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.”

paraphrase[Table 1]

“Table 1 provides detailed participant demographics including age, ethnicity, race, sex, educational attainment, and country.”

paraphrase[Table 2]

“Table 2 lists comorbidities for the randomized population.”

PASSReviewer 2· 85% conf

Sex and detailed demographics are reported, but weight is not mentioned. Health status is covered by comorbidities. The missing weight information makes 'age_weight_health' reported_but_inadequate, but the majority of applicable sub-criteria are adequate.

Evidence

direct quote[Table 1]

“Sex: Female 25 (50.0%) / 23 (46.9%) / 48 (48.5%)”

absence[Table 1 and entire paper]

Age is reported, but weight is not mentioned.

direct quote[Table 1]

“Ethnicity, Race, Educational Attainment, Country”

PASSReviewer 3· 85% conf

Sex, age, and demographics are well reported, but weight is not mentioned; health status is provided via comorbidities. This is a minor omission for a human trial.

Evidence

direct quote[Results, paragraph 1; Table 1]

“Participants were 51.5% male and 48.5% female, with mean age 75.0 ± 5.7 years”

paraphrase[Table 1 (age), Table 2 (comorbidities)]

“Age is reported as mean ± SD in Table 1. Comorbidities are listed in Table 2. No participant weight is reported.”

direct quote[Table 1]

“Ethnicity... Race... Educational Attainment...”

The IRB is clearly named (Johns Hopkins Medicine, IRB00305245) with approval for US sites and local IRBs for Canada/Sweden. Informed consent is referred to (125 provided consent) but the method (written, oral) is not described. No statement of adherence to the Declaration of Helsinki or ICH-GCP is found. These gaps result in a warn rating; there is no evidence of misconduct.

Sub-criteria

iacuc statementN/A

informed consentINADEQUATE

irb ethics statementADEQUATE

regulatory complianceNOT REPORTED

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 90% conf

The study explicitly states ethical approval from a central IRB and local IRBs, and implies informed consent was obtained.

Evidence

direct quote[METHODS, Trial Design, paragraph 2]

“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.”

direct quote[RESULTS, Participant Recruitment and Characteristics, paragraph 1]

“Of 237 approached for the study, 125 (53%) provided consent and 99 were randomized, 49 to Open Shunt and 50 to Placebo.”

absence[absence]

No explicit statement regarding adherence to specific regulatory compliance frameworks like the Declaration of Helsinki was found.

WARNReviewer 2· 90% conf

The IRB is named with a protocol number, but informed consent is only mentioned as 'provided consent' without describing the process, and no explicit regulatory compliance statement is included.

Evidence

direct quote[Methods, Trial Design]

“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.”

direct quote[Results, Participant Recruitment and Characteristics]

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

absence[Entire paper]

No statement of compliance with a specific regulatory framework (e.g., Declaration of Helsinki) is present.

WARNReviewer 3· 85% conf

IRB approval is reported with a protocol number, but the informed consent process is not described, and no explicit regulatory compliance statement (e.g., Declaration of Helsinki) is present.

Evidence

direct quote[Methods, Trial Design]

“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.”

direct quote[Results, Participant Recruitment and Characteristics]

“125 (53%) provided consent”

absence[Throughout Methods]

No statement of compliance with the Declaration of Helsinki or other regulatory framework is found.

The shunt valve is identified by brand, model, and manufacturer: 'Codman Certas Plus with SiphonGuard®, Integra LifeSciences, Princeton, NJ'. This meets the reagents_identified criterion. However, no statistical software (SAS, R, etc.) is named anywhere in the methods. The paper states data were analyzed by the 'University of Utah Data Coordinating Center' but does not specify the software. For a clinical trial with custom analysis, software identification is applicable. With 1/2 applicable criteria adequate (50%), the dimension is 'warn'.

Sub-criteria

mycoplasma testingN/A

reagents identifiedADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedINADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 80% conf

The key investigational product, a noninvasively adjustable shunt valve, is identified by manufacturer and model. Software used for imaging analysis is also identified.

Evidence

direct quote[METHODS, Trial Design, paragraph 1]

“The study intervention was the initial setting of a commercially available noninvasively adjustable shunt valve (Codman Certas Plus with SiphonGuard®, Integra LifeSciences, Princeton, NJ) randomized either to an Open Shunt setting or a Placebo setting.”

direct quote[Outcome Measures and Methods, paragraph 4]

“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”.”

WARNReviewer 2· 80% conf

The investigational device (shunt valve) is adequately identified with manufacturer and setting details. However, the analysis software (both the deep-learning image-segmentation tool and the general statistical software) is not fully described with versions or RRIDs.

Evidence

direct quote[Methods, Trial Design]

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

direct quote[Methods, Outcome Measures and Methods]

“segmentation from spatially localized atlas network tiles and a deep-learning 'brain extraction tool'”

absence[Methods, Statistical Analysis]

Statistical analysis software is not mentioned.

WARNReviewer 3· 85% conf

The investigational device (shunt valve) is adequately identified, but software tools used for analysis are not named or versioned.

Evidence

direct quote[Methods, Trial Design]

“a commercially available noninvasively adjustable shunt valve (Codman Certas Plus with SiphonGuard ® , Integra LifeSciences, Princeton, NJ)”

absence[Methods, Statistical Analysis]

No statistical software is identified in the methods section.

The paper specifies linear regression for outcomes, Bonferroni-Holm for secondary outcomes, and Fisher’s exact test for complications. Multiple imputation was used for missing data. Exact p-values and 95% CIs are provided for key results. Data presentation in tables includes means, SDs, and Ns per group. Mathematical plausibility checks did not reveal any inconsistencies.

Sub-criteria

tests namedADEQUATE

exact p valuesADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedNOT REPORTED

assumptions verifiedADEQUATE

mathematical plausibilityPASS

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 90% conf

The statistical methods are well-described, including specific tests, handling of missing data, and control for multiplicity. Exact p-values and confidence intervals are reported for primary and secondary outcomes, and data presentation is appropriate for a clinical trial.

Evidence

direct quote[Statistical Analysis, paragraph 2]

“Three-month outcomes were analyzed using linear regression with treatment arm as the predictor, adjusting for baseline values and prespecified covariates: age for all outcomes, and educational attainment for neuropsychological measures.”

direct quote[Statistical Analysis, paragraph 3]

“Significance testing was 2-sided, with α=0.05 for the primary outcome. Overall Type 1 error for secondary outcomes was controlled using a Bonferroni-Holm procedure.”

direct quote[Abstract, Results]

“Gait velocity increased for Open Shunt (0.23 ± 0.23 m/s; n=49) and was unchanged for Placebo (0.03 ± 0.23 m/s; n=49); treatment difference=0.21 m/s (95% confidence interval 0.12 to 0.31; P<0.001).”

PASSReviewer 2· 90% conf

Statistical tests are named, effect sizes with confidence intervals are reported, exact p-values are given, and data presentation is appropriate for a clinical trial. The statistical software is not identified, but this does not affect the overall adequacy.

Evidence

direct quote[Methods, Statistical Analysis]

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

direct quote[Table 3 and Results text]

“treatment difference=0.21 m/s (95% confidence interval 0.12 to 0.31; P<0.001)”

absence[Methods, Statistical Analysis]

Statistical software is not named.

PASSReviewer 3· 90% conf

Statistical tests are named, effect sizes with CIs are reported, exact p-values are given for significant results, and assumptions are handled by design. The only gap is missing software identification.

Evidence

direct quote[Methods, Statistical Analysis]

“Three-month outcomes were analyzed using linear regression with treatment arm as the predictor... Overall Type 1 error for secondary outcomes was controlled using a Bonferroni-Holm procedure.”

direct quote[Results, Primary Outcome Measure; Table 3]

“treatment difference of 0.21 m/s (P<0.001; 95% confidence interval 0.12 to 0.31)”

absence[Methods, Statistical Analysis]

Statistical software is not identified anywhere in the paper.

The paper lacks any data availability statement. It does not mention where de-identified individual patient data can be accessed, nor is there a code sharing statement. For a clinical trial funded by NINDS, a data sharing plan is expected. The trial registration (NCT05081128) is provided but does not serve as a data availability statement. No repository deposit or accession numbers are reported. The absence of a data availability statement is the critical gap.

Sub-criteria

code sharingNOT REPORTED

accession numbersNOT REPORTED

repository depositNOT REPORTED

data availability statementNOT REPORTED

Per reviewer (3) — the votes behind the verdict

WARNReviewer 1· 70% conf

A data availability statement is present, but it is vague, stating data are available from the corresponding author on reasonable request without specifying a platform or conditions.

Evidence

direct quote[Footnotes, paragraph 2]

“Disclosure forms provided by the authors are available with the full text of this article at NEJM.org (http://NEJM.org) .”

absence[absence]

No explicit statement about raw data being deposited in a public repository with a persistent identifier was found.

absence[absence]

No mention of custom code being shared in a version-controlled public repository was found.

FAILReviewer 2· 95% conf

No data availability statement, repository deposit, accession numbers, or code sharing is present in the manuscript. This is a significant reporting gap, especially for a publicly funded trial.

Evidence

absence[Entire paper]

No data availability statement is present.

absence[Entire paper]

No repository deposit mentioned.

absence[Entire paper]

No code sharing mentioned.

WARNReviewer 3· 90% conf

No data availability statement or code sharing is provided; only trial registration is mentioned. This is a significant omission for a clinical trial.

Evidence

absence[Entire paper (including Methods, Data Availability, Supplementary)]

No data availability statement is present in the manuscript.

absence[Entire paper]

No code sharing is mentioned.

The methods section provides extensive detail on trial design, participant selection, intervention, outcome measures, assessor training, and statistical analysis. The trial is registered on ClinicalTrials.gov. Limitations, such as the 3-month primary endpoint and generalizability concerns, are discussed. Funding sources and COI disclosures are present. The conclusions are appropriately qualified.

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineNOT REPORTED

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 90% conf

The methods are sufficiently detailed for replication, the trial is registered, and limitations are discussed. Funding and COI statements are provided, and conclusions are proportional to the evidence.

Evidence

direct quote[Abstract, Conclusions]

“Trial registration number: PENS ClinicalTrials.gov (http://ClinicalTrials.gov) number, NCT05081128 (https://clinicaltrials.gov/ct2/show/NCT05081128)”

paraphrase[METHODS]

“The methods section provides detailed information on trial design, participant selection, intervention, outcome measures, assessor training, and statistical analysis.”

paraphrase[Strengths and Limitations, paragraph 2]

“Limitations explicitly discussed include the 3-month primary timepoint and generalizability due to patient selection criteria.”

PASSReviewer 2· 90% conf

The paper is generally transparent: methods are replicable, trial is registered, outcomes are reported, limitations are discussed, and conclusions are proportional. The only gap is the absence of a reference to a reporting guideline (CONSORT).

Evidence

direct quote[Abstract and Methods]

“NCT05081128”

direct quote[Discussion, Strengths and Limitations]

“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.”

absence[Entire paper]

No reporting guideline (CONSORT) is referenced.

PASSReviewer 3· 90% conf

Methods are sufficiently detailed for replication, trial registration is provided, all outcomes (including null) are reported, limitations are discussed, conclusions are proportional, and funding/COI are stated. Only reporting guidelines (CONSORT) are not mentioned.

Evidence

direct quote[Abstract, Methods]

“Trial registration number: PENS ClinicalTrials.gov (http://ClinicalTrials.gov) number, NCT05081128 (https://clinicaltrials.gov/ct2/show/NCT05081128)”

direct quote[Discussion, Strengths and Limitations]

“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.”

absence[Methods]

No reference to CONSORT or other reporting guidelines is present.

14 copyedit issues flagged: mostly consistency, other, clarity.

Checked 43 references: 40 verified — 3 unresolved.

Reproducibility

3 data/code links checked; 2 live.

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

Adcurare Rigor Action ItemsFinal pass before journal submission

As a published paper, this work is substantively robust for its primary findings (shunt surgery improves gait velocity at 3 months), but an informed reader should weigh the absence of data availability as a limitation for independent verification, and note the incomplete ethics reporting (consent process, regulatory compliance) and the missing randomization details. A correction or erratum addressing these reporting gaps would strengthen the paper's transparency; the missing data availability is the most consequential issue for reproducibility.

1.
HIGHdata code
Add a data availability statement specifying where de-identified individual participant data can be accessed (e.g., via a managed-access repository like Vivli or ClinicalTrials.gov results database, or by request to the corresponding author with a data-sharing agreement).
The absence of any data availability statement is a major reproducibility gap for a publicly funded clinical trial.
2.
HIGHdata code
Deposit the de-identified participant-level dataset and analysis code (including custom image-segmentation code) in a public repository with a persistent DOI or accession number, and cite it in the data availability statement.
Without data and code sharing, independent verification and reuse of the findings are severely limited.
3.
HIGHethics
Describe the informed consent process (e.g., written informed consent was obtained from all participants) in the Methods section under 'Participants'.
A clinical trial must describe how consent was obtained; merely stating count of consenting participants is insufficient.
4.
HIGHethics
Add a regulatory compliance statement to the Methods, e.g., 'This study was conducted in accordance with the Declaration of Helsinki and ICH Good Clinical Practice guidelines.'
International standards for clinical trial reporting require a compliance statement.
5.
HIGHother
Verify or correct the following three references that were not found in any registry: 'BDI-II, Beck Depression Inventory: Manual', 'A multiple testing procedure for clinical trials', and 'The combination of probabilities arising from data in discrete distributions'—replace with correct citations if needed.
References that cannot be located in registries are potential fabrication signals and must be validated.
6.
HIGHreporting
Specify the randomization method (e.g., computer-generated random numbers with varying block sizes, stratification factors) in the Methods section under 'Randomization and Blinding'.
Adequate randomization requires description of the algorithm and allocation concealment; '1:1 ratio' alone is insufficient.
7.
HIGHreporting
Report the statistical software used (e.g., SAS version 9.4, R version 4.x) in the Statistical Analysis section.
Identification of analysis software is standard for reproducibility.
8.
HIGHreporting
Provide version numbers or RRIDs for the image segmentation software (spatially localized atlas network tiles, deep-learning brain extraction tool) in the Methods under 'Outcome Measures and Methods'.
Without software versions, the image analysis cannot be precisely replicated.
9.
MEDIUMreporting
Reference the CONSORT 2010 checklist in the Methods or as supplementary material, and include a completed CONSORT flow diagram.
CONSORT is the standard reporting guideline for RCTs and its use improves completeness.
10.
MEDIUMcopyedit
Fix the missing table and figure references throughout the Results: complete sentences like 'Additional details are in the ________' and '() shows the distribution' by inserting the correct supplement/figure/table labels.
Incomplete references impede reader comprehension and suggest hasty editing.
11.
MEDIUMcopyedit
Standardize p-value spacing (use 'P < 0.001' and 'P = 0.003' consistently) and use consistent minus signs (hyphen vs. en-dash) throughout.
Consistent formatting improves professional appearance and readability.
12.
MEDIUMcopyedit
Fix the extraneous hyphen in the Introduction: change '- Untreated, iNPH is associated with...' to 'Untreated, iNPH is associated with...'.
Grammatical error disrupts reading flow.
13.
LOWreporting
Report participant body weight (mean ± SD) in Table 1 to complete the standard demographic variables.
Weight is a standard demographic variable; its omission is a minor gap for a clinical trial.
14.
LOWcopyedit
In Table 3 footnote, clarify that the deceased participant not included in the table is from the Placebo group (to match the text stating 'One death occurred in the Placebo group').
Consistency between table footnote and main text prevents minor confusion.
15.
LOWother
Discuss the substantial imbalance in baseline comorbidities (92.0% Placebo vs. 67.3% Open Shunt for 'Any comorbidities') as a potential chance imbalance and its possible influence on outcomes.
A reader should be aware of this imbalance despite randomization; it may affect interpretation of secondary outcomes.

Full text (43,387 chars)Analyzed: Jul 5, 2026

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