Cited by 114Medication Adherence and ComplianceStatistical Methods in Clinical TrialsStatistical Methods and Bayesian Inference

Comparing compliance patterns between randomized treatments

Vrijens, Bernard, Goetghebeur, Els·1997·Controlled Clinical Trials

Abstract

When two equally efficacious drugs enter the market, the one with the better compliance is likely to be more widely used. Special management of the delivery may produce increased compliance. In this paper we analyze a trial of a single drug dosing prescription with patients randomized to either daily self monitoring of the outcome (blood pressure) or not. The study used Medication Event Monitoring Systems (MEMS) to record each exact time and date when a patient opened the pill container. No established method is available for comparing these high-dimensional compliance patterns between groups. This paper investigates several summary measures that highlight different dimensions of the pattern and the drug context in which they may be meaningful. Further, we examine conditional and marginal models that enable comparisons of the full pattern of daily dosing indicators for subjects between the groups. We found no simple difference in average compliance levels, but we found an interesting interaction between treatment and time: similar compliance existed initially among patients in both randomized groups, with a stronger decline over time for patients who did not monitor their blood pressure. We discuss how a balance between simplicity of interpretation and efficiency of data use may be sought in this case.

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Crossref · 10.1016/s0197-2456(96)00235-8

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Authors
Vrijens, B., & Goetghebeur, E.
Affiliations
  • Centre Hospitalier Universitaire de Liège (BE)
  • Transnational University Limburg (BE)
Corresponding author
Vrijens, Bernard
Venue
Controlled Clinical Trials
Publisher
Elsevier BV
Published
1997-06
Volume
18
Issue
3
Pages
187-203
ISSN
0197-2456 (ISSN-L)
OpenAlex
W2012961958
Cited by
114
References
15
Citations by year
2026: 1 · 2024: 1 · 2022: 1 · 2021: 2 · 2020: 4 · 2019: 2 · 2018: 1 · 2017: 3 · 2016: 3 · 2015: 7 · 2014: 2 · 2013: 4 · 2012: 12
FWCI
5.71
Type
journal article
Language
en
Open access
closed
Locations
  • Controlled Clinical Trials (publishedVersion)
  • PubMed (publishedVersion)
  • Ghent University Academic Bibliography (Ghent University) (submittedVersion)
  • Document Server@UHasselt (UHasselt) (submittedVersion)
Topics
  • Health Sciences › Medicine › Family Practice › Medication Adherence and Compliance
  • Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
  • Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods and Bayesian Inference
Keywords
medication adherence, self-monitoring, blood pressure, medication event monitoring system, summary measures, conditional models, marginal models, antihypertensive drugs
MeSH terms
Antihypertensive Agents, Blood Pressure, Drug Administration Schedule, Humans, Hypertension, Patient Compliance, Self Administration, Self Care, Models, Statistical, Blood Pressure Monitors, Bias, Randomized Controlled Trials as Topic

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