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Review
Peer-Review Record

Outcome Measures of Clinical Trials in Pediatric Chronic Kidney Disease

Future 2024, 2(2), 56-66; https://doi.org/10.3390/future2020005
by Ziyun Liang 1,†, Guohua He 2,3,†, Liyuan Tao 4, Xuhui Zhong 3, Tianxin Lin 5,6, Xiaoyun Jiang 2,* and Jie Ding 3,*
Reviewer 1: Anonymous
Reviewer 2: Anonymous
Reviewer 4: Anonymous
Future 2024, 2(2), 56-66; https://doi.org/10.3390/future2020005
Submission received: 13 December 2023 / Revised: 26 April 2024 / Accepted: 30 April 2024 / Published: 6 May 2024

Round 1

Reviewer 1 Report

Comments and Suggestions for Authors

This review is overall comprehensive and well written. It covers the major discussion points for the subject and will be interesting to the users to read.

Major point to address:

-        please check and complete references, as there are full paragraphs without even one reference

-        fix typo in line 132 (is follow-ep instead of -up)

-        change sentence in line 111, the word ‘recent’ is not adequate for studies from 1976 and 1997.

Author Response

Dear Reviewer,

Thank you very much for taking the time to review this manuscript. Please find the detailed responses below and the corresponding revisions/corrections highlighted/in track changes in the re-submitted files.

Point-to-point response

This review is overall comprehensive and well written. It covers the major discussion points for the subject and will be interesting to the users to read.

Response: Thank you.

please check and complete references, as there are full paragraphs without even one reference

Response: Thank you for pointing out this. To enhance the strength of our evidence, we add several references in the revised version, please see line 69, 86, 101, 103, 273, 275, 277, 284 377, 378, 408,417, 430, 433.

fix typo in line 132 (is follow-ep instead of -up)

Response: Thank you We have fixed it. Please see line 203 in the revised version “follow-up”.

change sentence in line 111, the word ‘recent’ is not adequate for studies from 1976 and 1997.

Response: Thank you. We have replaced the word ‘recent’ with ‘further’ in the revised version.

Please see line 181 “Contrary to earlier beliefs that GFR declines linearly once CKD is diagnosed, further research indicates that the progression may not be uniformly linear”.

Reviewer 2 Report

Comments and Suggestions for Authors

The authors reviewed the outcome measures of clinical trials conducted among the  pediatric CKD population. It is an important topic. I have a few suggestions to strength the manuscript.  

- For people who are not familiar with clinical trials, “Surrogate Outcome Indicators” and “alternative outcome measures” can be confusing?  Might be a good idea to provide the definitions first. For instance: A surrogate outcome can be defined as an outcome that can be observed sooner, at lower cost, or less invasively than the true outcome, and that enables valid inferences about the effect of intervention on the true outcome. Ref: Dialogues Clin Neurosci. 2006 Sep; 8(3): 345–352.

Please include which nation the organizations belong to. For instance, line 72, FDA is in the US; line 124, National Institute for Health and Care Excellence is in UK; 

 

-  IN this paper, the authors commented below a list of different sections lead by phrases in bold letters. Some of the sections are ‘parallel’ to each other (such as line 168, “Proteinuria – convincing”, line 178 “Blood pressure - convincing”) and some are the subgroups of a previous topic (line 80 “CKD Progression as Outcome Indicator” and line 83 “Clinical Outcome Indicator Defining KRT as CKD Progression” are under the line 71 “Clinical Outcome Measures” umbrella). The same Font style was used for all leading phrases, which can be confusing for the readers. I recommend fixing the overall flow prior to the publication.

Comments on the Quality of English Language

Many of the sentences are long and can be improved. To list a few: 

 - Line 48-50: Please consider “The concept of clinical trials was initially introduced in the medical field, notably documented in the New England Journal of Medicine in 1952 [8]. It underwent gradual refinement and updates as the medical era progressed.

 

-   Line 60-63: Please consider “In support of the continued development and assessment of clinical trials for pediatric CKD, this research retrieves information and articles related to clinical trials involving patients with pediatric CKD, sourced from both domestic and international registers. Subsequently, a comprehensive review of outcome indicators is conducted.

 

-    Line 73: “measuring” should be “measures”.

-     Line 77: “death, kidney replacement…” should be “death and kidney replacement….”

Author Response

Please see the attachment.

Author Response File: Author Response.pdf

Reviewer 3 Report

Comments and Suggestions for Authors

The introduction and the table has english mistakes. The table has inconsistent use of capital letters.

Regarding the indicators. Please specific target values for each indicator, even in the inconclusive category, and indicate your reasoning and evidence-based argument for suggesting these cut-off values.

You could add another table with the indicators and their level of evidence.

Comments on the Quality of English Language

It needs improvement, primarily until the "Alternative outcome measures" section.

Author Response

Please see the attachment.

Author Response File: Author Response.pdf

Reviewer 4 Report

Comments and Suggestions for Authors

Dear authors,

the subject chosen for this review is one of the most important for the pediatric nephrologist but also for the healthcare professional, related to burden of CKD for entire society.

Trials in children with chronic kidney disease do not consistently report outcomes that are critically important to patients and healthcare professionals.  For these reasons, your article can have the same importance. But you put in this article in major part the ancient references. I agree that the baseline is in the past, but a short search in PubMed revealed more than 17,000 articles on this topic after 2019. For example, the results of the SONG-Kids consensus. As part of the Standardized Outcomes in Nephrology—Children and Adolescents (SONG-Kids) initiative, two consensus workshops were convened in San Diego, California and Melbourne, Australia. Four themes were identified: survival and social life participation (high priority goals), capturing the whole child and family in healthcare decisions, ensuring broad relevance across the patient journey, and requiring feasible and valid measures. Or the results of KDIGO controversies and the CKiD study results. To be accepted, I think you must refresh all the references and develop the discussion section.

Good luck!

Author Response

Please see the attachment

Author Response File: Author Response.pdf

Round 2

Reviewer 2 Report

Comments and Suggestions for Authors

The manuscript has improved from the previous version. Regarding the context, I have recommend the following: 

 Line 200- 203. “Factors contributing to blood pressure readings higher than the 90th percentile include African-American ethnicity, absence of antihypertensive medication, and a relatively short duration of renal disease. Factors associated with uncontrolled hypertension include male gender and not being on ACE inhibitors or ARB therapy 48,49.”  Don’t think they are relevant to the context. Please consider deleting.

 

 

Line 251-253: Wrong citation. “However, it has been observed that children with uric acid levels below 5.5 mg/dL experienced a progression to advanced stages of CKD 17% to 38% faster than those with levels below 7.5 mg/dL”  The authors didn’t cite the study result correctly. It’s the opposite of what they wrote. Please correct. Here is what the original paper has “It is evident from these curves that those with uric acid of 5.5–7.5 and >7.5 mg/dL at the index visit had shorter times to event compared to individuals with index uric acid <5.5 mg/dL (log-rank Test P-values =0.04 and <0.0001, respectively)” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4658318/

Comments on the Quality of English Language

There are a few typos and sentences that need edits. 

Please stay with either “Pediatric” or “Paediatric” through the text.  

Line 36: affactted à affected

Line 49: introduced in à introduced into

Line 52-55:  Lengthy and repetitive sentences.  “Clinical trials are research studies that test a medical, surgical, or behavioral intervention in people.” Per NIH

Line 94: for marks à delete “for”

Line 99: delete “These limitations include:”

Line 151-152: delete “it is important to acknowledge that”

 

Line 294: please capitalize “Perspective” 

 

Author Response

Line 200- 203. “Factors contributing to blood pressure readings higher than the 90th percentile include African-American ethnicity, absence of antihypertensive medication, and a relatively short duration of renal disease. Factors associated with uncontrolled hypertension include male gender and not being on ACE inhibitors or ARB therapy 48,49.”  Don’t think they are relevant to the context. Please consider deleting.

 Response: Thank you. We have deleted the sentences in the revised manuscript.

Line 251-253: Wrong citation. “However, it has been observed that children with uric acid levels below 5.5 mg/dL experienced a progression to advanced stages of CKD 17% to 38% faster than those with levels below 7.5 mg/dL”  The authors didn’t cite the study result correctly. It’s the opposite of what they wrote. Please correct. Here is what the original paper has “It is evident from these curves that those with uric acid of 5.5–7.5 and >7.5 mg/dL at the index visit had shorter times to event compared to individuals with index uric acid <5.5 mg/dL (log-rank Test P-values =0.04 and <0.0001, respectively)” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4658318IF: 13.2 Q1 /

Response: Thank you for pointing out this. You’re right, we do make a mistake. So we revised the sentences, please see Line 353-355 in the revised version:” It has been observed that compared to children with uric acid levels below 5.5 mg/dL, those with uric acid levels of 5.5-7.5 or >7.5mg/dl experienced a 17% or 38% faster progression to advanced stages of CKD55.”

 

Comments on the Quality of English Language

There are a few typos and sentences that need edits. 

Please stay with either “Pediatric” or “Paediatric” through the text.  

Line 36: affactted à affected

Line 49: introduced in à introduced into

Line 52-55:  Lengthy and repetitive sentences.  “Clinical trials are research studies that test a medical, surgical, or behavioral intervention in people.” Per NIH

Line 94: for marks à delete “for”

Line 99: delete “These limitations include:”

Line 151-152: delete “it is important to acknowledge that”

Line 294: please capitalize “Perspective” 

Response: Thank you. We corrected these words and sentences in the revised manuscript.

  • We use “Pediatric” through the text.
  • We changed “affactted” into “affected” (Line 36)
  • We changed “introduced in” into “introduced into” (Line 49)
  • We revised the sentence as “Clinical trials are research studies that test a medical, surgical, or behavioral intervention in people9,10” and cited the NIH definition (Line 52-55)
  • We deleted “for” in “for marks” (Line 94)
  • We deleted “These limitations include” (Line 99)
  • We deleted “it is important to acknowledge that” (Line 151-152)
  • We capitalized “Perspective” (Line 294)

Reviewer 4 Report

Comments and Suggestions for Authors

no more question

Author Response

no more question

Response: Thank you.

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