Evidence map›Paper›PMID 31829279›Full record

ArticleTrials2019

Electronic health record nested pragmatic randomized controlled trial of a reminder system for serum lithium level monitoring in patients with mood disorder: KONOTORI study protocol.

Tomotsugu Seki, Morio Aki, Hirotsugu Kawashima, Tomotaka Miki, Shiro Tanaka, Koji Kawakami, Toshi A Furukawa

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.5field-weighted citation impact, top 33% of its field
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

4 citing papers in PubMed, 8 citations in OpenAlex.

  1. Trial
  2. Article
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  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

7 authors at 2 institutions in 1 country.

Tomotsugu SekiDepartment of Pharmacoepidemiology, Graduate School of Medicine/School of Public Health, Kyoto University, Kyoto, Japan.
Morio AkiDepartment of Psychiatry, Toyooka Hospital, Toyooka, Hyogo, Japan.
Hirotsugu KawashimaDepartment of Psychiatry, Toyooka Hospital, Toyooka, Hyogo, Japan.
Tomotaka MikiDepartment of Psychiatry, Toyooka Hospital, Toyooka, Hyogo, Japan.
Shiro TanakaDepartment of Clinical Biostatistics, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
Koji KawakamiDepartment of Pharmacoepidemiology, Graduate School of Medicine/School of Public Health, Kyoto University, Kyoto, Japan.
Toshi A FurukawaDepartment of Health Promotion and Human Behavior, Graduate School of Medicine/School of Public Health, Kyoto University, Kyoto, Japan. furukawa@kuhp.kyoto-u.ac.jp.ORCID http://orcid.org/0000-0003-2159-3776
Kyoto University · JPToyooka Hospital · JP

Funding

JSPS KAKENHI JP17H04122
6 · The paper itself

Abstract

backgroundThe weaknesses of classical explanatory randomized controlled trials (RCTs) include limited generalizability, high cost, and time burden. Pragmatic RCTs nested within electronic health records (EHRs) can be useful to overcome such limitations. Serum lithium monitoring has often been underutilized in real-world practice in Japan. This trial aims to evaluate the effectiveness of the EHR-nested reminder system for serum lithium level monitoring in the maintenance of therapeutic lithium concentration and in the improvement of the quality of care for patients on lithium maintenance therapy.

methodsThe Kyoto Toyooka nested controlled trial of reminders (KONOTORI trial) is an EHR-nested, parallel-group, superiority, stratified, permuted block-randomized controlled trial. Screening, random allocation, reminder output, and outcome collection will be conducted automatically by the EHR-nested trial program. Patients with a mood disorder taking lithium carbonate for maintenance therapy will be randomly allocated to the two-step reminder system for serum lithium monitoring or to usual care. The primary outcome is the achievement of therapeutic serum lithium concentration between 0.4 and 1.0 mEq/L at 18 months after informed consent. DISCUSSION: The KONOTORI trial uses EHRs to enable the efficient conduct of a pragmatic trial of the reminder system for lithium monitoring. This may contribute to improved quality of care for patients on lithium maintenance therapy.

trial registrationUniversity Hospital Medical Information Network (UMIN) Clinical Trials Registry, UMIN000033633. Registered on 3 July 2018.

Indexed as

Drug MonitoringElectronic Health RecordsReminder SystemsAntimanic AgentsEquivalence Trials as TopicHumansJapanLithium CarbonateMood DisordersPragmatic Clinical Trials as TopicTime FactorsTreatment OutcomeAntimanic AgentsLithium CarbonateElectronic health recordLithium carbonateMood disorderPragmatic trialRandomized controlled trial

Identifiers

PMID31829279
PMCPMC6907204
OpenAlexW2995031950

What OpenQuestion holds

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LicenceCC BY
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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.