Evidence map›Paper›PMID 39846234›Full record

ArticleACR open rheumatology2025

Effect of an Electronic Pill Bottle on Hydroxychloroquine Adherence in Pediatric Lupus: Results of a Novel Direct-to-Family Pilot Trial.

Rachel L Randell, Laura E Schanberg, Claire Beard, Thomas Phillips, Christoph P Hornik, Michael Cohen-Wolkowiez, Stephen J Balevic, with the CARRA Registry investigators

Abstract read
In one paragraph

Article in ACR open rheumatology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. 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.

Rachel L RandellDuke University and Duke Clinical Research Institute, Durham, North Carolina.ORCID https://orcid.org/0000-0002-8009-8209
Laura E SchanbergDuke University and Duke Clinical Research Institute, Durham, North Carolina.ORCID https://orcid.org/0000-0002-1913-6472
Claire BeardDuke Clinical Research Institute, Durham, North Carolina.
Thomas PhillipsDuke Clinical Research Institute, Durham, North Carolina.
Christoph P HornikDuke University and Duke Clinical Research Institute, Durham, North Carolina.
Michael Cohen-WolkowiezDuke University and Duke Clinical Research Institute, Durham, North Carolina.
Stephen J BalevicDuke University and Duke Clinical Research Institute, Durham, North Carolina.ORCID https://orcid.org/0000-0002-4016-1680
with the CARRA Registry investigators

Funding

UNC-Duke Collaborative Clinical Pharmacology Postdoctoral Training Program-Evaluation SupplementT32GM086330 · NIGMS · UNIV OF NORTH CAROLINA CHAPEL HILL · PI KIM L.R. BROUWER, Daniel Gonzalez · 2011 to 2026
$8.5M
Duke-UNC Collaborative Pediatric Clinical Pharmacology Postdoctoral Training ProgramT32HD104576 · NICHD · DUKE UNIVERSITY · PI BROUWER, KIM L.R., GONZALEZ, DANIEL · 2021 to 2025
$962k
Optimal Dosing for Biologic Agents in Obese Patients with Rheumatoid and Juvenile ArthritisK23AR075874 · NIAMS · DUKE UNIVERSITY · PI BALEVIC, STEPHEN JOSEPH · 2020 to 2024
$830k
FDA HHS U18 FD006298NIAMS NIH HHS K23 AR075874NICHD NIH HHS T32 HD104576NIGMS NIH HHS T32 GM086330NIH HHS K23AR075874NIH HHS T32GM086330NIH HHS T32HD104576U.S. Food and Drug Administration 5U18FD006298
6 · The paper itself

Abstract

objectiveThe objective of this study was to evaluate the preliminary effectiveness of an electronic pill bottle with automated reminders on hydroxychloroquine (HCQ) adherence in children with pediatric systemic lupus erythematosus (pSLE).

methodsThis was a self-controlled, open label, direct-to-family pilot trial. Children with pSLE treated with HCQ were recruited from the Childhood Arthritis and Rheumatology Research Alliance Registry. All participants received a pill bottle with a sensor in the cap to record openings and provide automated reminders, which were activated after a two-week run-in. The primary outcome was a change in adherence measured using the pill bottle over six months. Secondary outcomes included plasma HCQ concentrations and Medication Adherence Self-Report Inventory (MASRI) scores, collected during four home visits. An exploratory post hoc analysis examined adherence patterns over time.

resultsOverall adherence was high and did not change over six months (mean ± SD proportion of recorded out of expected pill bottle openings, 0.86 ± 0.20 and 0.89 ± 0.16, P = 0.590). A post hoc analysis grouped participants by adherence pattern. The group with variable adherence, compared with the group with persistent high adherence, had lower dose-adjusted HCQ concentrations at baseline (0.387 vs 0.627 ng/mL/mg, P = 0.04) and trended toward lower MASRI scores (77.1 vs 93.4, P = 0.09). After six months, there were no differences in HCQ concentrations or MASRI by group.

conclusionAutomated reminders did not improve adherence to HCQ for children with pSLE, although the ability to detect effect was limited by a high baseline adherence and small sample size. Post hoc analyses identified different adherence patterns and a subgroup of patients with low HCQ concentrations who could be targeted for future adherence interventions.

Identifiers

PMID39846234
PMCPMC11755115

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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.