Evidence map›Paper›PMID 39473996›Full record

ArticleGlomerular diseases

Preparation and Rationale for a Patient-Centered Clinical Outcome Assessment Set of Fluid Overload for Drug Development in Nephrotic Syndrome.

Eloise Salmon, Noelle E Carlozzi, Jin-Shei Lai, Catherine Spino, Yujie Wang, Emily Capellari, Rebecca Scherr, Kayla Sifre, Shawn Sullivan, Courtney Hurt and 6 more

Abstract read
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In one paragraph

Article in Glomerular diseases. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Clinical Trial End Points for Childhood CKD.Journal of the American Society of Nephrology : JASN · 2025
    Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors.

Eloise SalmonDepartment of Pediatrics, University of Michigan, Ann Arbor, MI, USA.
Noelle E CarlozziDepartment of Physical Medicine and Rehabilitation, University of Michigan, Ann Arbor, MI, USA.
Jin-Shei LaiDepartment of Medical Social Sciences, Northwestern University, Chicago, IL, USA.
Catherine SpinoDepartment of Biostatistics, University of Michigan, Ann Arbor, MI, USA.
Yujie WangDepartment of Pediatrics, University of Michigan, Ann Arbor, MI, USA.
Emily CapellariTaubman Health Sciences Library, University of Michigan, Ann Arbor, MI, USA.
Rebecca ScherrDepartment of Pediatrics, University of Michigan, Ann Arbor, MI, USA.
Kayla SifreDepartment of Pediatrics, University of Michigan, Ann Arbor, MI, USA.
Shawn SullivanDepartment of Pediatrics, University of Michigan, Ann Arbor, MI, USA.
Courtney HurtDepartment of Medical Social Sciences, Northwestern University, Chicago, IL, USA.
Tina CreguerDepartment of Pediatrics, University of Michigan, Ann Arbor, MI, USA.
Kelly HelmPatient Engagement, NephCure, Philadelphia, PA, USA.
Richard A LafayetteDepartment of Medicine, Stanford University, Stanford, CA, USA.
Patrick H NachmanDepartment of Medicine, University of Minnesota, Minneapolis, MN, USA.
David T SelewskiDepartment of Pediatrics, Medical University of South Carolina, Charleston, SC, USA.
John Devin PeipertDepartment of Medical Social Sciences, Northwestern University, Chicago, IL, USA.

Funding

FDA HHS UG3 FD007308FDA HHS UH3 FD007308
6 · The paper itself

Abstract

Introduction: Fluid overload is a source of substantial morbidity for adults and children with nephrotic syndrome (NS). Preparation and Rationale for a Fluid Overload in Nephrotic Syndrome Clinical Outcomes Assessment Set for Drug Development (Prepare-NS, 5UG3FD007308) was funded by the US Food and Drug Administration to develop a core set of patient-reported and observer-reported (for young children) outcome measures of fluid overload for use in pharmaceutical trials across the lifespan. Methods: The Prepare-NS study team developed the proposed context of use with input from stakeholders. We conducted a scoping review to assess the available literature on relevant patient- and observer-reported measures and performed secondary analyses of existing qualitative and quantitative data. Results: The outcome set will aim to serve individuals 2 years of age and older with primary NS conditions (specifically focal segmental glomerulosclerosis, minimal change disease, IgM nephropathy, membranous nephropathy, and childhood-onset NS not biopsied). The existing literature describing patient-reported outcomes in NS largely relies on nonspecific measures of health-related quality of life; fluid overload has been associated with lower scores on these measures. Conclusion: To address the gap in measure availability and fluid overload content, the Prepare-NS team has launched a set of qualitative studies for concept elicitation from the population of interest to inform development of new measures. The resulting measures subsequently will undergo psychometric evaluation and validation in a survey study.

Indexed as

Gap analysis and design manuscriptPatient-reported outcomesPrepare-NS rationaleSystematic review

Identifiers

PMID39473996
PMCPMC11521406

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.