Evidence map›Paper›PMID 31067237›Full record

Trial reportPLoS medicine2019

Individualized decision aid for diverse women with lupus nephritis (IDEA-WON): A randomized controlled trial.

Jasvinder A Singh, Liana Fraenkel, Candace Green, Graciela S Alarcón, Jennifer L Barton, Kenneth G Saag, Leslie M Hanrahan, Sandra C Raymond, Robert P Kimberly, Amye L Leong and 18 more

Registry-linked trialAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in PLoS medicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02319525 (Individualized Patient Decision Making for Treatment Choices Among Minorities With Lupus), which is not on this map. Cited by 23 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 3 pooled it
–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.

NCT02319525 nacompletednot on this map

Individualized Patient Decision Making for Treatment Choices Among Minorities With Lupus

TypeinterventionalSponsorUniversity of Alabama at BirminghamRan2014 to 2016Enrolled301ConditionsSystemic Lupus ErythematosusArmsComputerized patient decision-aid, Usual care (lupus pamphlet)
3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Decision aids for people facing health treatment or screening decisions.The Cochrane database of systematic reviews · 2024
    Pooled it
  3. Pooled it
  4. Article
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  7. Observational
  8. Observational
  9. Article
  10. Observational
  11. Article
  12. Review
  13. Article
  14. Review
  15. Article
  16. Patient-centred clinical trial design.Nature reviews. Nephrology · 2022
    Review
  17. Article
  18. Article
  19. Article
  20. 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

28 authors.

Jasvinder A SinghUniversity of Alabama at Birmingham, Birmingham, Alabama, United States of America.ORCID 0000-0003-3485-0006
Liana FraenkelYale University, New Haven, Connecticut, United States of America.
Candace GreenUniversity of Alabama at Birmingham, Birmingham, Alabama, United States of America.ORCID 0000-0002-9612-3528
Graciela S AlarcónUniversity of Alabama at Birmingham, Birmingham, Alabama, United States of America.
Jennifer L BartonOregon Health Science University, Portland, Oregon, United States of America.
Kenneth G SaagUniversity of Alabama at Birmingham, Birmingham, Alabama, United States of America.
Leslie M HanrahanLupus Foundation of America, Washington, DC, United States of America.
Sandra C RaymondLupus Foundation of America, Washington, DC, United States of America.
Robert P KimberlyUniversity of Alabama at Birmingham, Birmingham, Alabama, United States of America.
Amye L LeongHealthy Motivation, Inc., Los Angeles, California, United States of America.
Elyse ReyesElyse Reyes Consulting, Los Angeles, California, United States of America.
Richard L StreetTexas A&M University, College Station, Texas, United States of America.
Maria E Suarez-AlmazorUniversity of Texas MD Anderson Cancer Center, Houston, Texas, United States of America.
Guy S EakinArthritis Foundation, Atlanta, Georgia, United States of America.ORCID 0000-0003-2387-0693
Laura MarrowArthritis Foundation, Atlanta, Georgia, United States of America.ORCID 0000-0002-9594-0067
Charity J MorganUniversity of Alabama at Birmingham, Birmingham, Alabama, United States of America.
Brennda CaroGeorgia State University, Atlanta, Georgia, United States of America.
Jeffrey A SloanMayo Clinic School of Medicine, Rochester, Minnesota, United States of America.
Bochra JandaliBaylor College of Medicine, Houston, Texas, United States of America.
Salvador R GarciaBaylor College of Medicine, Houston, Texas, United States of America.ORCID 0000-0001-6773-1834
Jennifer GrossmanUniversity of California, Los Angeles (UCLA), Los Angeles, California, United States of America.
Kevin L WinthropOregon Health Science University, Portland, Oregon, United States of America.
Laura TrupinUniversity of California at San Francisco (UCSF), San Francisco, California, United States of America.ORCID 0000-0003-4046-200X
Maria Dall'EraUniversity of California at San Francisco (UCSF), San Francisco, California, United States of America.
Alexa MearaOhio State University, Columbus, Ohio, United States of America.
Tara RizviBaylor College of Medicine, Houston, Texas, United States of America.
W Winn ChathamUniversity of Alabama at Birmingham, Birmingham, Alabama, United States of America.
Jinoos YazdanyUniversity of California at San Francisco (UCSF), San Francisco, California, United States of America.

Funding

Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
RESOURCE-BASED CENTER FOR THE ADVANCEMENT OF PRECISION MEDICINE IN RHEUMATOLOGYP30AR070155 · NIAMS · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI Mary C Nakamura · 2016 to 2026
$8.2M
Goal concordance in rheumatoid arthritis in diverse populationsK23AR064372 · NIAMS · OREGON HEALTH & SCIENCE UNIVERSITY · PI BARTON, JENNIFER L · 2015 to 2019
$805k
NCATS NIH HHS UL1 TR001863NIAMS NIH HHS K23 AR064372NIAMS NIH HHS P30 AR070155
6 · The paper itself

Abstract

backgroundTreatment decision-making regarding immunosuppressive therapy is challenging for individuals with lupus. We assessed the effectiveness of a decision aid for immunosuppressive therapy in lupus nephritis. METHODS AND

findingsIn a United States multicenter, open-label, randomized controlled trial (RCT), adult women with lupus nephritis, mostly from racial/ethnic minority backgrounds with low socioeconomic status (SES), seen in in- or outpatient settings, were randomized to an individualized, culturally tailored, computerized decision aid versus American College of Rheumatology (ACR) lupus pamphlet (1:1 ratio), using computer-generated randomization. We hypothesized that the co-primary outcomes of decisional conflict and informed choice regarding immunosuppressive medications would improve more in the decision aid group. Of 301 randomized women, 298 were analyzed; 47% were African-American, 26% Hispanic, and 15% white. Mean age (standard deviation [SD]) was 37 (12) years, 57% had annual income of <$40,000, and 36% had a high school education or less. Compared with the provision of the ACR lupus pamphlet (n = 147), participants randomized to the decision aid (n = 151) had (1) a clinically meaningful and statistically significant reduction in decisional conflict, 21.8 (standard error [SE], 2.5) versus 12.7 (SE, 2.0; p = 0.005) and (2) no difference in informed choice in the main analysis, 41% versus 31% (p = 0.08), but clinically meaningful and statistically significant difference in sensitivity analysis (net values for immunosuppressives positive [in favor] versus negative [against]), 50% versus 35% (p = 0.006). Unresolved decisional conflict was lower in the decision aid versus pamphlet groups, 22% versus 44% (p < 0.001). Significantly more patients in the decision aid versus pamphlet group rated information to be excellent for understanding lupus nephritis (49% versus 33%), risk factors (43% versus 27%), medication options (50% versus 33%; p ≤ 0.003 for all); and the ease of use of materials was higher in the decision aid versus pamphlet groups (51% versus 38%; p = 0.006). Key study limitations were the exclusion of men, short follow-up, and the lack of clinical outcomes, including medication adherence.

conclusionsAn individualized decision aid was more effective than usual care in reducing decisional conflict for choice of immunosuppressive medications in women with lupus nephritis.

trial registrationClinicaltrials.gov, NCT02319525.

Indexed as

Decision Support TechniquesPatient Education as TopicPatient ParticipationAdultChoice BehaviorFemaleHealth Knowledge, Attitudes, PracticeHealth LiteracyHumansImmunosuppressive AgentsLupus NephritisMiddle AgedPamphletsTreatment OutcomeUnited StatesImmunosuppressive Agents

Identifiers

PMID31067237
PMCPMC6505936

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Registered trials

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.