Evidence map›Paper›PMID 30369087›Full record

ArticleArthritis care & research2019

Mock Recruitment for the Study of Antimalarials in an Incomplete Lupus Erythematosus Trial.

David R Karp, Benjamin F Chong, Judith A James, Cristina Arriens, Mariko Ishimori, Daniel J Wallace, Duanping Liao, Nancy J Olsen

Registry-linked trialAbstract read
In one paragraph

Article in Arthritis care & research, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03030118 (Study of Anti-Malarials in Incomplete Lupus Erythematosus), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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.

NCT03030118 phase2completednot on this map

Study of Anti-Malarials in Incomplete Lupus Erythematosus

TypeinterventionalSponsorMilton S. Hershey Medical CenterRan2017 to 2024Enrolled187ConditionsSystemic Lupus ErythematosusArmsHydroxychloroquine, Placebo Oral Capsule
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Trial
  2. Article
  3. Review
  4. 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

8 authors.

David R KarpUniversity of Texas Southwestern Medical Center, Dallas.ORCID 0000-0002-9005-1690
Benjamin F ChongUniversity of Texas Southwestern Medical Center, Dallas.
Judith A JamesOklahoma Medical Research Foundation and University of Oklahoma Health Sciences Center, Oklahoma City.
Cristina ArriensOklahoma Medical Research Foundation and University of Oklahoma Health Sciences Center, Oklahoma City.
Mariko IshimoriCedars-Sinai Medical Center, Los Angeles, California.
Daniel J WallaceCedars-Sinai Medical Center, Los Angeles, California.
Duanping LiaoPenn State College of Medicine, Hershey, Pennsylvania.
Nancy J OlsenPenn State College of Medicine, Hershey, Pennsylvania.

Funding

Tracking and Evaluation CoreU54GM104938 · NIGMS · UNIVERSITY OF OKLAHOMA HLTH SCIENCES CTR · PI Valerie Williams · 2013 to 2026
$68.2M
UT Southwestern Center for Translational Medicine (UL1/KL2/TL1)UL1TR001105 · NCATS · UT SOUTHWESTERN MEDICAL CENTER · PI TOTO, ROBERT DANIEL · 2013 to 2017
$24.5M
Oklahoma Rheumatic Disease Research Cores Center (Overall Application)P30AR073750 · NIAMS · OKLAHOMA MEDICAL RESEARCH FOUNDATION · PI JUDITH A JAMES · 2018 to 2026
$8.5M
SNP Confirmation and High Throughput Genotyping CoreP30AR053483 · NIAMS · OKLAHOMA MEDICAL RESEARCH FOUNDATION · PI GUTHRIDGE, JOEL MARVIN · 2007 to 2017
$6.7M
Hydroxychloroquine Treatment for Prevention of Systemic Lupus ErythematosusU34AR067392 · NIAMS · PENNSYLVANIA STATE UNIV HERSHEY MED CTR · PI KARP, DAVID R, OLSEN, NANCY J · 2015 to 2016
$683k
NCATS NIH HHS UL1 TR001105NIAMS NIH HHS P30 AR053483NIAMS NIH HHS P30 AR073750NIAMS NIH HHS U34 AR067392NIGMS NIH HHS U54 GM104938
6 · The paper itself

Abstract

objectiveRecruitment to randomized clinical trials is expensive and often falls short of goals, limiting achievement of measurable outcomes. To prepare for a trial in patients with incomplete forms of lupus, a mock recruitment protocol was carried out at 4 proposed study sites. The objective was to determine levels of interest in patients and to uncover potential barriers to enrollment.

methodsAfter obtaining institutional review board approval, study coordinators approached individuals who generally fit proposed criteria for the trial. A standardized script was followed in a structured interview. Levels of interest were determined and any reasons for concerns were collected with an open-ended format.

resultsA total of 45 subjects were interviewed, of which 73% expressed an interest in the trial, and 64% said they were likely to enroll. Concerns of those who were not interested included risk of hydroxychloroquine, desire not to receive placebo, and lack of time for participation.

conclusionThe mock recruitment suggests that the trial will be attractive to suitable patients. The concerns raised support other data indicating that provision of information is crucial to achieving enrollment goals. Mock recruitment of potential investigators should be considered also to address referral concerns.

Indexed as

Patient SelectionRandomized Controlled Trials as TopicAdolescentAdultAntimalarialsFemaleHumansLupus Erythematosus, SystemicMaleMiddle AgedYoung AdultAntimalarials

Identifiers

PMID30369087
PMCPMC6487234

What OpenQuestion holds

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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.