Evidence map›Paper›PMID 32556818›Full record

Observational studyDigestive diseases and sciences2021

Adherence to Adalimumab Was Not Improved by a Reminder-Based Intervention with an Electronic Needle Container.

Johannes P D Schultheiss, Sandra Altena, Max R Clevers, Dominique Baas, Bindia Jharap, Herma H Fidder

Abstract readMulticenter StudyObservational Study
In one paragraph

Observational study in Digestive diseases and sciences, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing 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

6 citing papers in PubMed.

  1. Review
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  6. Observational
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.

Johannes P D SchultheissDepartment of Gastroenterology and Hepatology, University Medical Center Utrecht, PO box L00.418, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands. j.p.d.schultheiss-7@umcutrecht.nl.ORCID 0000-0001-6111-0893
Sandra AltenaDepartment of Gastroenterology and Hepatology, University Medical Center Utrecht, PO box L00.418, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands.
Max R CleversDepartment of Gastroenterology and Hepatology, University Medical Center Utrecht, PO box L00.418, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands.
Dominique BaasDepartment of Hospital Pharmaceutics, Meander Medical Center Amersfoort, Maatweg 3, 3812 TZ, Amersfoort, The Netherlands.
Bindia JharapDepartment of Gastroenterology and Hepatology, Meander Medical Center Amersfoort, Maatweg 3, 3812 TZ, Amersfoort, The Netherlands.
Herma H FidderDepartment of Gastroenterology and Hepatology, University Medical Center Utrecht, PO box L00.418, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAdherence to adalimumab in inflammatory bowel disease (IBD) patients is reported to be below par. Non-adherence may result in loss-of-response and increased hospitalization. We analyzed the effect of an electronic needle container (ENC) on adherence to adalimumab.

methodsIn this multicenter, 12-months observational study, we included adalimumab treated IBD patients. All patients were invited to receive an ENC. Patients who declined or did not complete the registration for an ENC served as controls. Primary endpoint was whether an ENC increased adherence, calculated from pharmacy refills as proportion of days covered (PDC). Secondary endpoints were clinical outcomes, including loss-of-response, identification of predictors of adherence and correlation between different modalities for measuring adherence. Loss-of-response was defined as a disease flare, dose-escalation or IBD-related hospitalization or surgery.

resultsThe pharmacies' records identified 198 eligible patients, of whom 32 were excluded. The ENC was supplied to 69 patients, the remaining 97 patient formed the control group. Median baseline PDC (98.4% vs. 96.1%, p = 0.047) and the proportion of adherent (PDC ≥ 86%) patients (87.0% vs. 74.2%, p = 0.045) was higher for the ENC group. The ENC did not improve the adherence of patients during follow-up (odds ratio 1.26, 95% CI 0.55-2.86). During follow-up, five (7.2%) patients in the ENC group and 13 (13.4%) in the control group discontinued adalimumab (log-rank p = 0.22). Loss-of-response occurred in 12 (17.4%) and 14 (14.4%) patients, respectively (log-rank p = 0.66).

conclusionsOur results show no beneficial effect of a reminder-based intervention on adherence or treatment outcomes.

Indexed as

Medication AdherenceAdalimumabAdultColitis, UlcerativeCrohn DiseaseDrug Administration ScheduleFemaleHumansInjectionsMaleMiddle AgedNetherlandsReminder SystemsTime FactorsTreatment OutcomeTumor Necrosis Factor InhibitorsAdalimumabTumor Necrosis Factor InhibitorsAdalimumabAnti-TNFCrohn’s diseaseInflammatory bowel diseaseMedication adherenceUlcerative colitis

Identifiers

PMID32556818
PMCPMC8053164

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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.