{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,8]],"date-time":"2026-05-08T06:02:07Z","timestamp":1778220127401,"version":"3.51.4"},"reference-count":14,"publisher":"S. Karger AG","issue":"1","license":[{"start":{"date-parts":[[2024,8,5]],"date-time":"2024-08-05T00:00:00Z","timestamp":1722816000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2024,8,5]],"date-time":"2024-08-05T00:00:00Z","timestamp":1722816000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Glomerular Dis"],"abstract":"<jats:p>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. <\/jats:p>","DOI":"10.1159\/000539921","type":"journal-article","created":{"date-parts":[[2024,8,5]],"date-time":"2024-08-05T21:05:23Z","timestamp":1722891923000},"page":"172-182","source":"Crossref","is-referenced-by-count":4,"title":["Preparation and Rationale for a Patient-Centered Clinical Outcome Assessment Set of Fluid Overload for Drug Development in Nephrotic Syndrome"],"prefix":"10.1159","volume":"4","author":[{"given":"Eloise","family":"Salmon","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Noelle E.","family":"Carlozzi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jin-Shei","family":"Lai","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Catherine","family":"Spino","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yujie","family":"Wang","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Emily","family":"Capellari","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rebecca","family":"Scherr","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kayla","family":"Sifre","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shawn","family":"Sullivan","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Courtney","family":"Hurt","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tina","family":"Creguer","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kelly","family":"Helm","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Richard A.","family":"Lafayette","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Patrick H.","family":"Nachman","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David T.","family":"Selewski","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"John Devin","family":"Peipert","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"127","published-online":{"date-parts":[[2024,8,5]]},"reference":[{"key":"ref1","doi-asserted-by":"publisher","DOI":"10.1016\/j.kint.2021.04.027"},{"key":"ref2","doi-asserted-by":"publisher","DOI":"10.2215\/CJN.13231215"},{"key":"ref3","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpeds.2017.03.034"},{"key":"ref4","doi-asserted-by":"publisher","DOI":"10.7326\/M18-0850"},{"key":"ref5","doi-asserted-by":"publisher","DOI":"10.1016\/j.xkme.2021.01.013"},{"key":"ref6","doi-asserted-by":"publisher","DOI":"10.1038\/ki.2012.428"},{"key":"ref7","doi-asserted-by":"publisher","DOI":"10.1053\/j.ajkd.2018.07.020"},{"key":"ref8","doi-asserted-by":"publisher","DOI":"10.1007\/s11136-021-02925-y"},{"key":"ref9","doi-asserted-by":"publisher","DOI":"10.1093\/ckj\/sfz092"},{"key":"ref10","doi-asserted-by":"publisher","DOI":"10.1186\/s12955-017-0737-2"},{"key":"ref11","doi-asserted-by":"publisher","DOI":"10.1007\/s00467-015-3074-x"},{"key":"ref12","doi-asserted-by":"publisher","DOI":"10.1186\/1477-7525-11-30"},{"key":"ref13","doi-asserted-by":"publisher","DOI":"10.1053\/j.ajkd.2017.04.023"},{"key":"ref14","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2010.04.011"}],"container-title":["Glomerular Diseases"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/karger.com\/gdz\/article-pdf\/4\/1\/172\/4280904\/000539921.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/karger.com\/gdz\/article-pdf\/4\/1\/172\/4280904\/000539921.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,4,23]],"date-time":"2025-04-23T15:26:59Z","timestamp":1745422019000},"score":1,"resource":{"primary":{"URL":"https:\/\/karger.com\/article\/doi\/10.1159\/000539921"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,8,5]]},"references-count":14,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2024,6,20]]}},"URL":"https:\/\/doi.org\/10.1159\/000539921","archive":["Portico"],"relation":{"is-supplemented-by":[{"id-type":"doi","id":"10.6084\/m9.figshare.26469643","asserted-by":"subject"}]},"ISSN":["2673-3633"],"issn-type":[{"value":"2673-3633","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,8,5]]}}}