Evidence map›Paper›PMID 39578016›Full record

ArticleLupus science & medicine2024

Evaluation and randomised controlled trial of home urinalysis testing in patients with SLE at elevated risk for developing lupus nephritis: a study protocol.

Heather T Gold, Omar El Shahawy, Peter M Izmirly, Mala Masson, Brooke Cohen, Jill P Buyon

Abstract readClinical Trial Protocol
In one paragraph

Article in Lupus science & medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

6 authors.

Heather T GoldDepartment of Population Health, NYU Grossman School of Medicine, New York City, New York, USA Heather.Gold@nyumc.org.ORCID 0000-0002-5896-0499
Omar El ShahawyDepartment of Population Health, NYU Grossman School of Medicine, New York City, New York, USA.
Peter M IzmirlyDepartment of Medicine, NYU Grossman School of Medicine, New York City, New York, USA.
Mala MassonDepartment of Medicine, NYU Grossman School of Medicine, New York City, New York, USA.
Brooke CohenDepartment of Medicine, NYU Grossman School of Medicine, New York City, New York, USA.
Jill P BuyonDepartment of Medicine, NYU Grossman School of Medicine, New York City, New York, USA.ORCID 0000-0002-3852-7129

Funding

HEALTH: Harnessing Epidemiology to Advance Lupus Treatment and HealthU01DP006700 · DP · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · PI BUYON, JILL P, GOLD, HEATHER T · 2022 to 2025
$3.6M
ACL HHS U01DP006700NCCDPHP CDC HHS U01 DP006700
6 · The paper itself

Abstract

introductionLupus nephritis (LN) is a frequent complication of SLE, occurring in up to 60% of adult patients and ultimately progressing from acute inflammation to chronicity with fibrosis and end-stage kidney failure in 10%-30% of patients. Racial/ethnic minority patients with lupus have worse long-term outcomes, including progression to end-stage renal disease and overall mortality. A major challenge in the management of patients with SLE is delayed identification of early kidney disease, which ultimately leads to a greater burden on both patients and the health system. METHODS AND ANALYSIS: Using a mixed methods approach, this study will develop, adapt and evaluate a home urine sampling protocol with a text-messaging reminder and data capture system for patients at elevated risk of de novo LN or relapse. First, a feasibility pilot using a single-group trial design (n=18) will be implemented, with a feasibility assessment and qualitative, debriefing interviews with patients to further refine the intervention. The second phase is a comparative effectiveness trial of the intervention (n=160) with the primary outcome of biopsy eligibility, that is, the participant has a clinical indication for a kidney biopsy (urine protein-creatinine ratio≥0.5), whether or not the patient actually undergoes the biopsy procedure. The randomised trial includes an economic evaluation of the adapted home urinalysis protocol. DISCUSSION AND DISSEMINATION: It is unknown whether weekly home-based urine sampling can identify proteinuria sooner than standard care; if found sooner, kidney problems could be diagnosed earlier, hopefully leading to earlier care for less-involved disease and subsequent reduced morbidity. The data collected in this trial will inform future feasibility and effectiveness of text-messaging-based home urine sampling interventions. TRIAL REGISTRATION NUMBER: The randomised trial will be registered with ClincialTrials.gov prior to enrolment start.

Indexed as

Lupus NephritisUrinalysisAdultFeasibility StudiesFemaleHumansLupus Erythematosus, SystemicMalePilot ProjectsRandomized Controlled Trials as TopicClinical TrialLupus Erythematosus, SystemicLupus Nephritis

Identifiers

PMID39578016
PMCPMC11590779

What OpenQuestion holds

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Registered trials

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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.